Draft Guidance for Industry on Qualification of Exacerbations of Chronic Pulmonary Disease Tool for Measurement of Symptoms of Acute Bacterial Exacerbation of Chronic Bronchitis in Patients With Chronic Obstructive Pulmonary Disease; Availability, 1873-1874 [2014-00259]
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Federal Register / Vol. 79, No. 7 / Friday, January 10, 2014 / Notices
recommendations must be submitted in
any one of the following ways:
1. Electronically. You may send your
comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) that are accepting
comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number ll, Room C4–26–05,
7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ Web site address at
https://www.cms.hhs.gov/
PaperworkReductionActof1995.
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
Reports Clearance Office at (410) 786–
1326.
SUPPLEMENTARY INFORMATION:
Contents
This notice sets out a summary of the
use and burden associated with the
following information collections. More
detailed information can be found in
each collection’s supporting statement
and associated materials (see
ADDRESSES).
mstockstill on DSK4VPTVN1PROD with NOTICES
CMS–102 and 105 Clinical Laboratory
Improvement Amendments of 1988
(CLIA) Budget Workload Reports and
Supporting Regulations
CMS–10209 Medicare Advantage
Chronic Care Improvement Program
(CCIP) and Quality Improvement (QI)
Project Reporting Tools
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.
The term ‘‘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
requires federal agencies to publish a
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16:40 Jan 09, 2014
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60-day notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, before
submitting the collection to OMB for
approval. To comply with this
requirement, CMS is publishing this
notice.
Information Collections
1. Type of Information Collection
Request: Extension without change of a
currently approved collection; Title of
Information Collection: Clinical
Laboratory Improvement Amendments
of 1988 (CLIA) Budget Workload
Reports and Supporting Regulations;
Use: We will use the collected
information to determine the amount of
Federal reimbursement for surveys
conducted. Use of the information
includes program evaluation, audit,
budget formulation and budget
approval. Form CMS–102 is a multipurpose form designed to capture and
record all budget and expenditure data.
Form CMS–105 captures the annual
projected CLIA workload that the State
survey agency will accomplish. Our
regional offices also use the information
to approve the annual projected CLIA
workload. The information is required
as part of the section 1864 agreement
with the state. Form Numbers: CMS–102
and CMS–105 (OCN: 0938–0599);
Frequency: Quarterly; Affected Public:
State, Local, or Tribal Governments;
Number of Respondents: 50; Total
Annual Responses: 50; Total Annual
Hours: 4,500. (For policy questions
regarding this collection contact Angela
Stancel at 410–786–4876.)
2. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Medicare
Advantage Chronic Care Improvement
Program (CCIP) and Quality
Improvement (QI) Project Reporting
Tools; Use: Medicare Advantage
Organizations (MAOs) are required to
have an ongoing quality improvement
(QI) program that meets our
requirements and includes at least one
chronic care improvement program
(CCIP) and one QI Project. Every MAO
must have a QI program that monitors
and identifies areas where
implementing appropriate interventions
would improve patient outcomes and
patient safety. Information collected
using the CCIP and QIP reporting tools
is an integral resource for oversight,
monitoring, compliance, and auditing
activities necessary to ensure high
quality value-based health care for
Medicare beneficiaries. Form Number:
CMS–10209 (OCN: 0938–1023);
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Frequency: Yearly; Affected Public:
Private sector (Business or other forprofits and Not-for-profit institutions);
Number of Respondents: 1,904; Total
Annual Responses: 1,904; Total Annual
Hours: 28,560. (For policy questions
regarding this collection contact Ellen
Dieujuste at 410–786–2191).
Dated: January 6, 2014.
Martique Jones,
Deputy Director, Regulations Development
Group, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2014–00195 Filed 1–9–14; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–1630]
Draft Guidance for Industry on
Qualification of Exacerbations of
Chronic Pulmonary Disease Tool for
Measurement of Symptoms of Acute
Bacterial Exacerbation of Chronic
Bronchitis in Patients With Chronic
Obstructive Pulmonary Disease;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Qualification of
Exacerbations of Chronic Pulmonary
Disease Tool for Measurement of
Symptoms of Acute Bacterial
Exacerbation of Chronic Bronchitis in
Patients with Chronic Obstructive
Pulmonary Disease.’’ This draft
guidance provides a statement of
qualification for the Exacerbations of
Chronic Pulmonary Disease Tool
(EXACT) patient-reported outcome
instrument and summarizes the concept
of interest and context of use (COU) for
which the tool is qualified through the
Center for Drug Evaluation and
Research’s (CDER’s) drug development
tool (DDT) qualification program.
Qualification of the EXACT represents a
conclusion that, within the stated COU,
the instrument can be relied on to have
a specific interpretation and application
in drug development and regulatory
review. This draft guidance is an
attachment to the guidance for industry
entitled ‘‘Qualification Process for Drug
Development Tools.’’
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
SUMMARY:
E:\FR\FM\10JAN1.SGM
10JAN1
1874
Federal Register / Vol. 79, No. 7 / Friday, January 10, 2014 / Notices
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by April 10, 2014.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201,
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 draft guidance document.
Submit electronic comments on the
draft 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:
Elektra J. Papadopoulos, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6429,
Silver Spring, MD 20993–0002, 301–
796–0900.
SUPPLEMENTARY INFORMATION:
mstockstill on DSK4VPTVN1PROD with NOTICES
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Qualification of Exacerbations of
Chronic Pulmonary Disease Tool for
Measurement of Symptoms of Acute
Bacterial Exacerbation of Chronic
Bronchitis in Patients with Chronic
Obstructive Pulmonary Disease.’’
In March 2006, FDA issued the
‘‘Critical Path Opportunities Report and
List’’, in which FDA described six key
areas along the critical path to improved
therapies and listed specific
opportunities for advancement within
these topic areas. The report noted that
a new product development toolkit
containing new scientific and technical
methods was needed to improve the
efficiency of drug development.
Innovative and improved DDTs can
help streamline the drug development
process, improve the chances for
clinical trial success, and yield more
information about a treatment and/or
disease. DDTs include, but are not
limited to, biomarkers and clinical
outcome assessments (COAs). CDER has
developed a formal process, the DDT
qualification process, to work with
developers of these tools to guide them
as they refine the tools and rigorously
evaluate them for use in the regulatory
context. Once qualified, DDTs will be
publicly available for use in any drug
VerDate Mar<15>2010
16:40 Jan 09, 2014
Jkt 232001
development program for the qualified
COU. COA DDTs are developed and
reviewed using this process when they
are intended ultimately for use as
primary or secondary endpoints in
clinical trials designed to provide
substantial evidence of treatment
benefit. Upon qualification by CDER, a
qualification statement is provided
describing the concept of interest and
COU for which the tool is qualified.
This draft guidance describes the
qualification statement for the EXACT,
a COA DDT.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the Agency’s current thinking
on the qualification of the EXACT COA
DDT. 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. 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.
III. 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: January 6, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–00259 Filed 1–9–14; 8:45 am]
BILLING CODE 4160–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0136]
Draft Guidance for Industry on
Community-Acquired Bacterial
Pneumonia: Developing Drugs for
Treatment; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Community-Acquired
Bacterial Pneumonia: Developing Drugs
for Treatment.’’ The purpose of this
draft guidance is to assist clinical trial
sponsors and investigators in the
development of antibacterial drugs for
the treatment of community-acquired
bacterial pneumonia (CABP). The
science of clinical trial design and our
understanding of this disease have
advanced in recent years, and this draft
guidance informs sponsors of our
current recommendations for clinical
development. FDA is specifically
requesting comment on critical areas of
scientific interest including the
appropriate primary efficacy endpoints,
the use of an intent-to-treat (ITT)
population for the primary analysis
population, and the use of antibacterial
therapy by patients before participating
in clinical trials. This draft guidance
revises the draft guidance of the same
name that published March 20, 2009.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by April 10, 2014.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201,
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 draft guidance document.
Submit electronic comments on the
draft 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.
SUMMARY:
E:\FR\FM\10JAN1.SGM
10JAN1
]]>Agencies
[Federal Register Volume 79, Number 7 (Friday, January 10, 2014)]
[Notices]
[Pages 1873-1874]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-00259]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-D-1630]
Draft Guidance for Industry on Qualification of Exacerbations of
Chronic Pulmonary Disease Tool for Measurement of Symptoms of Acute
Bacterial Exacerbation of Chronic Bronchitis in Patients With Chronic
Obstructive Pulmonary Disease; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Qualification
of Exacerbations of Chronic Pulmonary Disease Tool for Measurement of
Symptoms of Acute Bacterial Exacerbation of Chronic Bronchitis in
Patients with Chronic Obstructive Pulmonary Disease.'' This draft
guidance provides a statement of qualification for the Exacerbations of
Chronic Pulmonary Disease Tool (EXACT) patient-reported outcome
instrument and summarizes the concept of interest and context of use
(COU) for which the tool is qualified through the Center for Drug
Evaluation and Research's (CDER's) drug development tool (DDT)
qualification program. Qualification of the EXACT represents a
conclusion that, within the stated COU, the instrument can be relied on
to have a specific interpretation and application in drug development
and regulatory review. This draft guidance is an attachment to the
guidance for industry entitled ``Qualification Process for Drug
Development Tools.''
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
[[Page 1874]]
considers your comment on this draft guidance before it begins work on
the final version of the guidance, submit either electronic or written
comments on the draft guidance by April 10, 2014.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201, 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 draft guidance document.
Submit electronic comments on the draft 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: Elektra J. Papadopoulos, Center for
Drug Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6429, Silver Spring, MD 20993-0002, 301-
796-0900.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Qualification of Exacerbations of Chronic Pulmonary Disease
Tool for Measurement of Symptoms of Acute Bacterial Exacerbation of
Chronic Bronchitis in Patients with Chronic Obstructive Pulmonary
Disease.''
In March 2006, FDA issued the ``Critical Path Opportunities Report
and List'', in which FDA described six key areas along the critical
path to improved therapies and listed specific opportunities for
advancement within these topic areas. The report noted that a new
product development toolkit containing new scientific and technical
methods was needed to improve the efficiency of drug development.
Innovative and improved DDTs can help streamline the drug
development process, improve the chances for clinical trial success,
and yield more information about a treatment and/or disease. DDTs
include, but are not limited to, biomarkers and clinical outcome
assessments (COAs). CDER has developed a formal process, the DDT
qualification process, to work with developers of these tools to guide
them as they refine the tools and rigorously evaluate them for use in
the regulatory context. Once qualified, DDTs will be publicly available
for use in any drug development program for the qualified COU. COA DDTs
are developed and reviewed using this process when they are intended
ultimately for use as primary or secondary endpoints in clinical trials
designed to provide substantial evidence of treatment benefit. Upon
qualification by CDER, a qualification statement is provided describing
the concept of interest and COU for which the tool is qualified. This
draft guidance describes the qualification statement for the EXACT, a
COA DDT.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on the
qualification of the EXACT COA DDT. 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. 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.
III. 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: January 6, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-00259 Filed 1-9-14; 8:45 am]
BILLING CODE 4160-01-P
