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, 50028-50030 [E8-19626]
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50028
Federal Register / Vol. 73, No. 165 / Monday, August 25, 2008 / Notices
typically require that a certification
form accompany the application/
submission, as described in our April
2008 Draft Guidance. Added to the
burden were generic applications/
submissions, which were originally not
included in the burden calculations, but
have since been determined to require a
certification form accompany the
application/submission.
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Investigational
Applications
Marketing
Applications
Hours per
Response
Total Hours
CDER (new application)
1,837
----
.25
459
CBER (new application)
206
----
.25
52
CDER (amendment)
20,969
----
.25
5,242
CBER (amendment)
826
----
.25
207
CDER (annual report)
4,764
.25
1,191
CBER (annual report)
878
.25
220
CDER/CBER (new application/resubmission)
----
214
.75
161
CDRH (new application)
----
424
.75
318
CDER/CBER (amendment)
----
4,451
.75
3,338
CDRH (amendment)
----
2,267
.75
1,700
CDER/CBER (efficacy supplement/resubmission)
----
259
.75
194
CDER (annual report)
----
7,753
.75
5,815
CBER (annual report)
----
629
.75
472
CDER/CBER (labeling supplement)
----
1,273
.75
955
CDRH (supplement)
----
2,526
.75
1,895
CDRH (annual report)
433
.75
325
OGD (original)
563
.75
422
OGD ( BE amendment/supplement)
477
.75
358
OGD (labeling supplement)
723
.75
542
5,173
.75
3,880
OGD (annual report)
TOTAL
1 There
27,746
are no capital costs or operating and maintenance costs associated with this collection of information.
ebenthall on PRODPC60 with NOTICES
We believe the estimate of 27,746
hours per year accurately reflects the
burden. We recognize that individuals
or entities less familiar with FDA forms
and the clinical trials data bank
(ClinicalTrials.gov) may require greater
than 15 and 45 minutes (depending on
the type of application/submission) per
response.
Dated: August 19, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–19625 Filed 8–22–08; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0259]
AGENCY:
ACTION:
Food and Drug Administration,
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
VerDate Aug<31>2005
15:18 Aug 22, 2008
Jkt 214001
Fax written comments on the
collection of information by September
24, 2008.
DATES:
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
HHS.
BILLING CODE 4160–01–S
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.
PO 00000
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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
ADDRESSES:
E:\FR\FM\25AUN1.SGM
25AUN1
50029
Federal Register / Vol. 73, No. 165 / Monday, August 25, 2008 / Notices
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 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 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 premeeting 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:
ebenthall on PRODPC60 with NOTICES
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Reporting Activity
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
Designation Request
64
1.28
82
60
4,915
Premeeting Packages
54
1.11
60
100
6,000
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50030
Federal Register / Vol. 73, No. 165 / Monday, August 25, 2008 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued
No. of
Respondents
Reporting Activity
Total
118
1There
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–N–0087] (formerly
Docket No. 2007N–0461)
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Mental Models
Study of Communicating With Health
Care Providers About the Risks and
Benefits of Prescription Drug Use for
Pregnant and Nursing Women With
Chronic Conditions
AGENCY:
Food and Drug Administration,
HHS.
ebenthall on PRODPC60 with NOTICES
Total Annual
Responses
2.39
Hours per
Response
142
Total Hours
160
10,915
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]
ACTION:
Annual Frequency
per Response
Notice.
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–NEW and title,
‘‘Mental Models Study of
Communicating with Health Care
Providers about the Risks and Benefits
of Prescription Drug Use for Pregnant
and Nursing Women with Chronic
Conditions.’’ Also include the FDA
docket number found in brackets in the
heading of this document.
VerDate Aug<31>2005
15:18 Aug 22, 2008
Jkt 214001
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3794.
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.
Mental Models Study of
Communicating With Health Care
Providers About the Risks and Benefits
of Prescription Drug Use for Pregnant
and Nursing Women With Chronic
Conditions
The authority for FDA to collect the
information derives from the FDA
Commissioner’s authority, as specified
in section 903(d)(2) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C.
393(d)(2)).
The proposed information collection
will help FDA advance public health by
identifying misperceptions and
knowledge gaps about how health care
providers use information to make
decisions about the use of prescription
drugs for the targeted patient groups.
Knowledge of these misperceptions and
gaps provides opportunities for FDA to
target its communications more
precisely to such gaps and areas of
misperception in health care providers’
mental models regarding treatment
decisions.
FDA engages in various
communication activities to ensure that
patients and health care providers have
the information they need to make
informed decisions about treatment
options, including the use of
prescription drugs. FDA regulations (21
CFR 201.57) describe the content of
required product labeling, and FDA
reviewers ensure that labeling contains
accurate and complete information
about the known risks and benefits of
each drug. This data collection and
analysis is designed to identify
knowledge gaps that FDA could then
address, which would ultimately
improve decision making and
potentially improve health outcomes.
The project will use ‘‘mental
modeling,’’ a qualitative research
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
method that compares a model of the
decision-making processes of a group or
groups to an ‘‘expert model’’ of the same
decision-making processes developed
from expert knowledge and experience.
In this study, the decision models of
certain health care providers concerning
treatment options for pregnant and
nursing women will be compared to an
expert model concerning such treatment
options that was derived from the
knowledge and experience of FDA
reviewers responsible for product
labeling. FDA will use telephone
interviews to determine from the health
care providers the factors that influence
their treatment decisions for pregnant
and nursing women with chronic
conditions. A comparison between
expert and health care provider models
based on the collected information may
identify consequential knowledge gaps
that can be redressed through messages
or information campaigns designed by
FDA.
Using a protocol derived from the
research that resulted in the ‘‘expert
model,’’ trained interviewers will
conduct one-on-one telephone
discussions with 24 to 30 members of
each of 2 categories of health care
providers (described in the following
paragraph) who provide health care
services to pregnant and nursing
women.
The two categories of health care
providers are:
(1) Those who directly care for
pregnant and nursing women, including
obstetricians, OB/GYNs (obstetrician/
gynecologists), nurse midwives, and
primary care practitioners.
(2) Selected specialties of healthcare
providers who directly care for women
of reproductive age who have chronic
health conditions (allergists,
psychiatrists, neurologists, and
cardiologists).
In the Federal Register of December
11, 2007 (72 FR 70328), 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:
E:\FR\FM\25AUN1.SGM
25AUN1
]]>Agencies
[Federal Register Volume 73, Number 165 (Monday, August 25, 2008)]
[Notices]
[Pages 50028-50030]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-19626]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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\
----------------------------------------------------------------------------------------------------------------
Reporting No. of Annual Frequency Total Annual Hours per
Activity Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
Designation 64 1.28 82 60 4,915
Request
----------------------------------------------------------------------------------------------------------------
Premeeting 54 1.11 60 100 6,000
Packages
----------------------------------------------------------------------------------------------------------------
[[Page 50030]]
Total 118 2.39 142 160 10,915
----------------------------------------------------------------------------------------------------------------
\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
