Laboratory Site Tours Program, 60477-60478 [2014-23844]
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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This guidance finalizes the draft
guidance issued May 30, 2012 (77 FR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
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17:15 Oct 06, 2014
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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:
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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
60478
Federal Register / Vol. 79, No. 194 / Tuesday, October 7, 2014 / Notices
knowledge of product analyses used by
tobacco product manufacturers to
ensure product consistency.
Dated: September 30, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
II. Description of Site Tours Program
[FR Doc. 2014–23844 Filed 10–6–14; 8:45 am]
plans and instruments or request more
information on the proposed project
contact: Keisha Shropshire, NIMH
Project Clearance Liaison, Science
Policy and Evaluation Branch, OSPPC,
NIMH, NIH, Neuroscience Center, 6001
Executive Boulevard, MSC 9667,
Rockville Pike, Bethesda, MD 20892, or
call 301–443–4335 or Email your
request, including your address to:
nimhprapubliccomments@mail.nih.gov.
Formal requests for additional plans and
instruments must be requested in
writing.
BILLING CODE 4164–01–P
In the Laboratory Site Tours Program,
small groups of CTP staff plan to
observe the operations of laboratories
that perform testing and analyses of
tobacco products and tobacco smoke
relative to analytical chemistry,
microbiology, toxicology, biomarkers of
exposure or risk, and analytical method
development. Please note that the
Laboratory Site Tours Program is not
intended to include official FDA
inspections of facilities to determine
compliance with the FD&C Act or for
the purposes of developing Tobacco
Product Manufacturing Practice
regulations; rather, the program is meant
to educate CTP staff and improve their
understanding of laboratory testing and
analyses used by the tobacco industry.
III. Site Selection
CTP plans to select a wide variety of
laboratories that include academic,
private, and those affiliated with
tobacco manufacturers. All travel
expenses associated with the site tours
will be the responsibility of CTP. Final
site selections will be based on the
availability of CTP funds and resources
for the relevant fiscal year, as well as the
following factors, if applicable: (1)
Compliance status of the requesting
facility and affiliated firm, (2) whether
the requesting facility is in arrears for
user fees, and (3) whether the requesting
facility or affiliated firm has a
significant request or marketing
application or submission pending with
FDA.
IV. Requests for Participation
Identify requests for participation
with the docket number found in
brackets in the heading of this
document. Received requests are
available for public examination in the
Division of Dockets Management (see
ADDRESSES) between 9 a.m. and 4 p.m.,
Monday through Friday.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request; NIMH Database of
Cognitive Training and Remediation
Studies (DCTRS) (NIMH)
Proposed Collection
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on April 15, 2014,
pages 21250–21252 and allowed 60days for public comment. No public
comments were received. The purpose
of this notice is to allow an additional
30 days for public comment. The
National Institute of Mental Health
(NIMH), National Institutes of Health,
may not conduct or sponsor, and the
respondent is not required to respond
to, an information collection that has
been extended, revised, or implemented
on or after October 1, 1995, unless it
displays a currently valid OMB control
number.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs, OIRA_submission@
omb.eop.gov or by fax to 202–395–6974,
Attention: NIH Desk Officer.
Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30-days of the date of
this publication.
FOR FURTHER INFORMATION CONTACT: To
obtain a copy of the data collection
SUMMARY:
NIMH Database of Cognitive Training
and Remediation Studies (DCTRS)—
New—National Institute of Mental
Health (NIMH), National Institute of
Health (NIH).
Need and Use of Information
Collection: The NIMH Database of
Cognitive Training and Remediation
Studies (DCTRS) is an integrated
database that includes study- and
subject-level data from studies of
cognitive remediation (CR) in
schizophrenia. DCTRS will allow NIMH
staff and interested investigators to
examine the ways in which various
patient characteristics, intervention
approaches and features, and treatment
combinations affect responses to
remediation. The DCTRS Study
Information Form and Data Submission
Agreement are necessary for the
‘‘Submitter’’ to request permission to
submit study data to the NIMH DCTRS
for general research purposes. The
primary use of this information is to
collect submitter information and study
information for inclusion in the NIMH
DCTRS database. The DCTRS data
submission agreement includes two
forms: (1) The data submission form that
includes the terms, agreement,
submitter information and certifications,
and (2) the study information form
which collects de-identified data for
each study.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
60.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
ESTIMATED ANNUALIZED BURDEN HOURS
Form
Type of
respondent
Number of
respondents
Frequency of
response
Average time
per response
(in hours)
Annual hour
burden
Data Submission Agreement ............
Principal Investigators/Physicians ....
12
1
5
60
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]]>Agencies
[Federal Register Volume 79, Number 194 (Tuesday, October 7, 2014)]
[Notices]
[Pages 60477-60478]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-23844]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration's (FDA's) Center for Tobacco
Products' (CTP) Office of 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)
[[Page 60478]]
knowledge of product analyses used by tobacco product manufacturers to
ensure product consistency.
II. Description of Site Tours Program
In the Laboratory Site Tours Program, small groups of CTP staff
plan to observe the operations of laboratories that perform testing and
analyses of tobacco products and tobacco smoke relative to analytical
chemistry, microbiology, toxicology, biomarkers of exposure or risk,
and analytical method development. Please note that the Laboratory Site
Tours Program is not intended to include official FDA inspections of
facilities to determine compliance with the FD&C Act or for the
purposes of developing Tobacco Product Manufacturing Practice
regulations; rather, the program is meant to educate CTP staff and
improve their understanding of laboratory testing and analyses used by
the tobacco industry.
III. Site Selection
CTP plans to select a wide variety of laboratories that include
academic, private, and those affiliated with tobacco manufacturers. All
travel expenses associated with the site tours will be the
responsibility of CTP. Final site selections will be based on the
availability of CTP funds and resources for the relevant fiscal year,
as well as the following factors, if applicable: (1) Compliance status
of the requesting facility and affiliated firm, (2) whether the
requesting facility is in arrears for user fees, and (3) whether the
requesting facility or affiliated firm has a significant request or
marketing application or submission pending with FDA.
IV. Requests for Participation
Identify requests for participation with the docket number found in
brackets in the heading of this document. Received requests are
available for public examination in the Division of Dockets Management
(see ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday.
Dated: September 30, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-23844 Filed 10-6-14; 8:45 am]
BILLING CODE 4164-01-P
