Pathological Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint To Support Accelerated Approval; Guidance for Industry; Availability, 60476-60477 [2014-23845]
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60476
Federal Register / Vol. 79, No. 194 / Tuesday, October 7, 2014 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR Section/FDA Form
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
316.10, 316.12, and 316.14 .................................................
316.20, 316.21, and 316.26 .................................................
Form FDA 3671 ...................................................................
316.22 ..................................................................................
316.27 ..................................................................................
316.30 ..................................................................................
316.36 ..................................................................................
2
225
50
65
43
450
2
1
2
3
1
1
1
3
2
450
150
65
43
450
6
100
150
45
2
5
3
15
200
67,500
6,750
130
215
1,350
90
Total ..............................................................................
........................
........................
........................
........................
76,235
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 1, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
collection and has assigned OMB
control number 0910–0693. The
approval expires on August 31, 2017. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
[FR Doc. 2014–23846 Filed 10–6–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: October 1, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
Food and Drug Administration
[FR Doc. 2014–23842 Filed 10–6–14; 8:45 am]
[Docket No. FDA–2014–N–0222]
BILLING CODE 4164–01–P
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Guidance for Industry on User Fee
Waivers, Reductions, and Refunds for
Drug and Biological Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Guidance for Industry on User Fee
Waivers, Reductions, and Refunds for
Drug and Biological Products’’ has been
approved by the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995.
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: On July
16, 2014, the Agency submitted a
proposed collection of information
entitled ‘‘Guidance for Industry on User
Fee Waivers, Reductions, and Refunds
for Drug and Biological Products’’ to
OMB for review and clearance under 44
U.S.C. 3507. An Agency may not
conduct or sponsor, and a person is not
required to respond to, a collection of
information unless it displays a
currently valid OMB control number.
OMB has now approved the information
asabaliauskas on DSK5VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:15 Oct 06, 2014
Jkt 235001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–D–0432]
Pathological Complete Response in
Neoadjuvant Treatment of High-Risk
Early-Stage Breast Cancer: Use as an
Endpoint To Support Accelerated
Approval; Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Pathological Complete
Response in Neoadjuvant Treatment of
High-Risk Early-Stage Breast Cancer:
Use as an Endpoint to Support
Accelerated Approval.’’ This guidance
is intended to assist applicants in
designing trials to support marketing
approval of drugs to treat breast cancer
in the neoadjuvant (preoperative) setting
using pathological complete response
(pCR) as a surrogate endpoint that could
support approval under the accelerated
approval regulations. Despite advances
in systemic therapy of early-stage breast
cancer over the past few decades, there
remains a significant unmet medical
need for certain high-risk or poor
prognosis populations of early-stage
SUMMARY:
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
breast cancer patients. This guidance is
intended to encourage industry
innovation and expedite the
development of breakthrough therapies
to treat high-risk early-stage breast
cancer. This guidance finalizes the draft
guidance issued May 30, 2012.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of this guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Tatiana Prowell, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 2112,
Silver Spring, MD 20993–0002, 301–
796–2330.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Pathological Complete Response in
Neoadjuvant Treatment of High-Risk
Early-Stage Breast Cancer: Use as an
Endpoint to Support Accelerated
Approval.’’ Under the accelerated
approval regulations (21 CFR part 314,
subpart H, and 21 CFR part 601, subpart
E), FDA may grant marketing approval
for a new drug on the basis of adequate
and well-controlled trials establishing
E:\FR\FM\07OCN1.SGM
07OCN1
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 194 / Tuesday, October 7, 2014 / Notices
that the drug has an effect on a surrogate
endpoint that is reasonably likely to
predict clinical benefit (e.g., in earlystage breast cancer, an improvement in
disease-free or overall survival),
provided that the applicant conducts
additional trials or collects additional
data after approval to verify and
describe the predicted clinical benefit.
This guidance is intended to assist
applicants in designing trials to support
marketing approval of drugs to treat
breast cancer in the neoadjuvant
(preoperative) setting using pCR as a
surrogate endpoint that could support
approval under the accelerated approval
regulations. The guidance provides
acceptable definitions of pCR for
regulatory purposes. The guidance also
describes appropriate patient
populations for inclusion in
neoadjuvant trials conducted with
regulatory intent. Finally, the guidance
outlines critical design features of trials
for both accelerated approval and
confirmation of clinical benefit to
support regular approval.
FDA recognizes that despite advances
in adjuvant systemic therapy of breast
cancer over the past few decades, there
remains a significant unmet medical
need for certain high-risk or poor
prognosis populations of early-stage
breast cancer patients. Developing
highly effective new drugs for these
populations is an FDA priority. In
providing guidance on the use of pCR as
a surrogate endpoint that could support
accelerated approval in the neoadjuvant
setting, FDA hopes to encourage
industry innovation and expedite the
development and widespread
availability of highly effective novel
therapies to treat high-risk early-stage
breast cancer.
This guidance finalizes the draft
guidance issued May 30, 2012 (77 FR
31858). The current version clarifies
appropriate trial designs and
development strategies to support
accelerated approval in the neoadjuvant
setting, defines acceptable endpoints for
accelerated approval and confirmation
of clinical benefit, standardizes the
approach to postoperative systemic
therapy, includes guidelines for
evaluation of the axillary lymph nodes,
and provides detailed recommendations
for pathology standard operating
procedures.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the Agency’s
current thinking on use of pCR as an
endpoint to support accelerated
approval of drug and biological
products to treat high-risk early-stage
breast cancer patient populations. It
VerDate Sep<11>2014
17:15 Oct 06, 2014
Jkt 235001
does not create or confer any rights for
or on any person and does not operate
to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
II. The Paperwork Reduction Act of
1995
This guidance refers to previously
approved collections of information that
are subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR parts 312 and
314 have been approved under OMB
control numbers 0910–0014 and 0910–
0001, respectively. The collections of
information for special protocol
assessments have been approved under
OMB control number 0910–0470.
III. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: October 1, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–23845 Filed 10–6–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1208]
Laboratory Site Tours Program
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration’s (FDA’s) Center for
Tobacco Products’ (CTP) Office of
SUMMARY:
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
60477
Science is announcing an invitation for
participation in its Laboratory Site
Tours Program. This program is
intended to give CTP staff an
opportunity to visit facilities involved
in the testing and analysis of tobacco
products and tobacco smoke. These
visits are intended to provide CTP staff
with the opportunity to gain a better
understanding of tobacco science and
laboratory operations and are not
intended as regulatory inspections or
facility visits for the purposes of
developing Tobacco Product
Manufacturing Practice regulations. The
purpose of this notice is to invite parties
interested in participating in the
Laboratory Site Tours Program to submit
their requests to CTP.
DATES: Submit either an electronic or
written request for participation in this
program by December 8, 2014. The
request should include a description of
your facility, including, as applicable, a
list of the types of testing and analyses
of tobacco products and tobacco smoke
performed. Please specify the physical
address(es) of the site(s) for which you
are submitting a request, along with a
proposed 1-day tour agenda.
ADDRESSES: If your facility is interested
in offering a site visit, submit either an
electronic request to https://
www.regulations.gov or a written
request to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Carolyn Dresler, Center for Tobacco
Products, Food and Drug
Administration, 10903 New Hampshire
Ave., Document Control Center, Bldg.
71, rm. G335, Silver Spring, MD 20993–
0002, 240–402–4067, carolyn.dresler@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
On June 22, 2009, the Family
Smoking Prevention and Tobacco
Control Act (Pub. L. 111–31) was signed
into law, amending the Federal Food,
Drug, and Cosmetic Act (the FD&C Act)
and giving FDA authority to regulate
tobacco product manufacturing,
distribution, and marketing.
CTP’s Office of Science is conducting
the Laboratory Site Tours Program to
provide its scientific and regulatory staff
the opportunity to gain a better
understanding of tobacco science and
laboratory operations, to include
tobacco product testing and analysis.
CTP’s goal for the Laboratory Site Tours
Program is for its staff to gain: (1)
Firsthand exposure to laboratories that
perform tobacco product testing and (2)
E:\FR\FM\07OCN1.SGM
07OCN1
]]>Agencies
[Federal Register Volume 79, Number 194 (Tuesday, October 7, 2014)]
[Notices]
[Pages 60476-60477]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-23845]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-D-0432]
Pathological Complete Response in Neoadjuvant Treatment of High-
Risk Early-Stage Breast Cancer: Use as an Endpoint To Support
Accelerated Approval; Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Pathological
Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage
Breast Cancer: Use as an Endpoint to Support Accelerated Approval.''
This guidance is intended to assist applicants in designing trials to
support marketing approval of drugs to treat breast cancer in the
neoadjuvant (preoperative) setting using pathological complete response
(pCR) as a surrogate endpoint that could support approval under the
accelerated approval regulations. Despite advances in systemic therapy
of early-stage breast cancer over the past few decades, there remains a
significant unmet medical need for certain high-risk or poor prognosis
populations of early-stage breast cancer patients. This guidance is
intended to encourage industry innovation and expedite the development
of breakthrough therapies to treat high-risk early-stage breast cancer.
This guidance finalizes the draft guidance issued May 30, 2012.
DATES: Submit either electronic or written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for single copies of this guidance
to the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.
Submit electronic comments on the guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Tatiana Prowell, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 2112, Silver Spring, MD 20993-0002, 301-
796-2330.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Pathological Complete Response in Neoadjuvant Treatment of
High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support
Accelerated Approval.'' Under the accelerated approval regulations (21
CFR part 314, subpart H, and 21 CFR part 601, subpart E), FDA may grant
marketing approval for a new drug on the basis of adequate and well-
controlled trials establishing
[[Page 60477]]
that the drug has an effect on a surrogate endpoint that is reasonably
likely to predict clinical benefit (e.g., in early-stage breast cancer,
an improvement in disease-free or overall survival), provided that the
applicant conducts additional trials or collects additional data after
approval to verify and describe the predicted clinical benefit. This
guidance is intended to assist applicants in designing trials to
support marketing approval of drugs to treat breast cancer in the
neoadjuvant (preoperative) setting using pCR as a surrogate endpoint
that could support approval under the accelerated approval regulations.
The guidance provides acceptable definitions of pCR for regulatory
purposes. The guidance also describes appropriate patient populations
for inclusion in neoadjuvant trials conducted with regulatory intent.
Finally, the guidance outlines critical design features of trials for
both accelerated approval and confirmation of clinical benefit to
support regular approval.
FDA recognizes that despite advances in adjuvant systemic therapy
of breast cancer over the past few decades, there remains a significant
unmet medical need for certain high-risk or poor prognosis populations
of early-stage breast cancer patients. Developing highly effective new
drugs for these populations is an FDA priority. In providing guidance
on the use of pCR as a surrogate endpoint that could support
accelerated approval in the neoadjuvant setting, FDA hopes to encourage
industry innovation and expedite the development and widespread
availability of highly effective novel therapies to treat high-risk
early-stage breast cancer.
This guidance finalizes the draft guidance issued May 30, 2012 (77
FR 31858). The current version clarifies appropriate trial designs and
development strategies to support accelerated approval in the
neoadjuvant setting, defines acceptable endpoints for accelerated
approval and confirmation of clinical benefit, standardizes the
approach to postoperative systemic therapy, includes guidelines for
evaluation of the axillary lymph nodes, and provides detailed
recommendations for pathology standard operating procedures.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking on use of pCR as an endpoint to support
accelerated approval of drug and biological products to treat high-risk
early-stage breast cancer patient populations. It does not create or
confer any rights for or on any person and does not operate to bind FDA
or the public. An alternative approach may be used if such approach
satisfies the requirements of the applicable statutes and regulations.
II. The Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR parts 312 and 314 have
been approved under OMB control numbers 0910-0014 and 0910-0001,
respectively. The collections of information for special protocol
assessments have been approved under OMB control number 0910-0470.
III. Comments
Interested persons may submit either electronic comments regarding
this document to https://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.
Dated: October 1, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-23845 Filed 10-6-14; 8:45 am]
BILLING CODE 4164-01-P
