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, 60476 [2014-23842]
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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
]]>Agencies
[Federal Register Volume 79, Number 194 (Tuesday, October 7, 2014)]
[Notices]
[Page 60476]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-23842]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0222]
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.
-----------------------------------------------------------------------
SUMMARY: 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
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.
Dated: October 1, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-23842 Filed 10-6-14; 8:45 am]
BILLING CODE 4164-01-P
