Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease, a Patient-Reported Outcome, for the Measurement of Severity of Respiratory Symptoms in Stable Chronic Obstructive Pulmonary Disease: Qualification for Exploratory Use; Draft Guidance for Industry; Availability, 12506-12508 [2016-05224]
Download as PDF
<![CDATA[
12506
Federal Register / Vol. 81, No. 46 / Wednesday, March 9, 2016 / Notices
regarding the salience of information in
text. The questionnaire is available
upon request. Participation is estimated
to take approximately 20 minutes.
To examine differences between
experimental conditions, we will
conduct inferential statistical tests such
as analysis of variance.
Pretesting will take place before the
main study to select super sizes for the
main study and to evaluate the
procedures and measures that will be
used. We will exclude individuals who
work in health care or marketing
settings because their knowledge and
experiences may not reflect those of the
average consumer. We conducted a
priori power analyses to determine
sample sizes for the pretest and the
main study.
FDA estimates the burden of this
collection of information as follows:
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Number of
responses per
respondent
Total annual
responses
Average burden per
response
Total hours
Pretesting
No. to complete the screener (assumes 50% eligible).
No. of completes ..................................................
338
1
338
0.08 (5 minutes) ............
27
240
1
240
0.33 (20 minutes) ..........
79
Main Study
No. to complete the screener (assumes 50% eligible).
No. of completes ..................................................
1,785
1
1,785
0.08 (5 minutes) ............
143
1,272
1
1,272
0.33 (20 minutes) ..........
420
Total ..............................................................
........................
........................
........................
.......................................
669
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Lhorne on DSK5TPTVN1PROD with NOTICES
IV. References
1. Hall, R.H. and P. Hanna, ‘‘The Impact of
Web page Text-Background Colour
Combinations on Readability, Retention,
Aesthetics and Behavioural Intention,’’
Behaviour & Information Technology,
2004;23:183–195.
2. Baur, C. and C. Prue, ‘‘The CDC Clear
Communication Index Is a New
Evidence-Based Tool to Prepare and
Review Health Information,’’ Health
Promotion Practice, 2014;15:629–637.
3. Shrank, W., J. Avorn, C. Rolon, et al.,
‘‘Effect of Content and Format of
Prescription Drug Labels on Readability,
Understanding, and Medication Use: A
Systematic Review,’’ The Annals of
Pharmacotherapy, 2007;41:783–801.
4. Wogalter, M.S. and W.J. Vigilante, Jr.,
‘‘Effects of Label Format on Knowledge
Acquisition and Perceived Readability
by Younger and Older Adults,’’
Ergonomics, 2003;46:327–344.
5. Smither, J.A.A. and C.C. Braun,
‘‘Readability of Prescription Drug Labels
by Older and Younger Adults,’’ Journal
of Clinical Psychology in Medicine
Settings, 1994;1:149–159.
6. Foxman, E.R., D.D. Muehling, and P.A.
Moore, ‘‘Disclaimer Footnotes in Ads:
Discrepancies Between Purpose and
Performance,’’ Journal of Public Policy &
Marketing, 1988;7:127–137.
7. Murray, N.M., L.A. Manrai, and A.K.
Manrai, ‘‘Public Policy Relating to
Consumer Comprehension of Television
Commercials: A Review and Some
Empirical Results,’’ Journal of Consumer
Policy, 1993;16:145–170.
8. Manrai, L.A., A.K. Manrai, and N. Murray,
‘‘Comprehension of Info-Aid Supers in
Television Advertising for Social Ideas:
Implications for Public Policy,’’ Journal
of Business Research, 1994;30:75–84.
VerDate Sep<11>2014
15:08 Mar 08, 2016
Jkt 238001
9. Hill, A. and L. Scharff, ‘‘Readability of
Computer Displays as a Function of
Colour, Saturation, and Background
Texture.’’ In: D. Harns (Ed.) Engineering
Psychology and Cognitive Ergonomics,
(Vol. 4) Ashgate, Aldershot, United
Kingdom.
10. Shieh, K.-K. and C.-C. Lin, ‘‘Effects of
Screen Type, Ambient Illumination, and
Color Combination on VDT Visual
Performance and Subjective Preference,’’
International Journal of Industrial
Ergonomics, 2000;26:527–536.
11. Tinker, M.A. and D.G. Paterson, ‘‘Studies
of Typographical Factors Influencing
Speed of Reading. VII. Variations in
Color of Print and Background,’’ Journal
of Applied Psychology, 1931;15:471–479.
12. Legge, G.E., G.S. Rubin, and A. Luebner,
‘‘Psychophysics of Reading—V. The Role
of Contrast in Normal Vision,’’ Vision
Research, 1987;27:1165–1177.
13. Kaufman, D.W., J.P. Kelly, L. Rosenberg,
et al., ‘‘Recent Patterns of Medication
Use in the Ambulatory Adult Population
of the United States: The Slone Survey,’’
The Journal of the American Medical
Association, 2002;287:337–344.
Dated: March 2, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–05233 Filed 3–8–16; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–0712]
Evaluating Respiratory Symptoms in
Chronic Obstructive Pulmonary
Disease, a Patient-Reported Outcome,
for the Measurement of Severity of
Respiratory Symptoms in Stable
Chronic Obstructive Pulmonary
Disease: Qualification for Exploratory
Use; Draft Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Evaluating Respiratory Symptoms in
Chronic Obstructive Pulmonary Disease,
a Patient-Reported Outcome, for the
Measurement of Severity of Respiratory
Symptoms in Stable Chronic
Obstructive Pulmonary Disease:
Qualification for Exploratory Use.’’ This
draft guidance provides a statement of
qualification for exploratory use for the
evaluating respiratory symptoms in
chronic obstructive pulmonary disease
(E–RS: COPD), a 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
SUMMARY:
E:\FR\FM\09MRN1.SGM
09MRN1
Federal Register / Vol. 81, No. 46 / Wednesday, March 9, 2016 / Notices
and Research’s (CDER’s) drug
development tool (DDT) qualification
program. Qualification for exploratory
use of the E–RS: COPD 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
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 June 7, 2016.
ADDRESSES: You may submit comments
as follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Lhorne on DSK5TPTVN1PROD with NOTICES
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
VerDate Sep<11>2014
15:08 Mar 08, 2016
Jkt 238001
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2016–D–0712 for ‘‘Evaluating
Respiratory Symptoms in Chronic
Obstructive Pulmonary Disease, a
Patient-Reported Outcome, for the
Measurement of Severity of Respiratory
Symptoms in Stable Chronic
Obstructive Pulmonary Disease:
Qualification for Exploratory Use; Draft
Guidance for Industry; Availability.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on https://
www.regulations.gov. Submit both
copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
12507
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
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, 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 draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Elektra Papadopoulos, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6377,
Silver Spring, MD 20993–0002, 301–
796–0900.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Evaluating Respiratory Symptoms in
Chronic Obstructive Pulmonary Disease,
a Patient-Reported Outcome, for the
Measurement of Severity of Respiratory
Symptoms in Stable Chronic
Obstructive Pulmonary Disease:
Qualification for Exploratory Use.’’
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
E:\FR\FM\09MRN1.SGM
09MRN1
12508
Federal Register / Vol. 81, No. 46 / Wednesday, March 9, 2016 / Notices
describing the concept of interest and
COU for which the tool is qualified.
This draft guidance describes the
qualification statement for the E–RS:
COPD, 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 current thinking of FDA
on the qualification for exploratory use
of the E–RS: COPD. It does not establish
any rights for any person and is not
binding on FDA or the public. You can
use an alternative approach if it satisfies
the requirements of the applicable
statutes and regulations.
II. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: March 2, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–05224 Filed 3–8–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–0814]
Pediatric Study Plans: Content of and
Process for Submitting Initial Pediatric
Study Plans and Amended Initial
Pediatric Study Plans; Draft Guidance
for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘Pediatric
Study Plans: Content of and Process for
Submitting Initial Pediatric Study Plans
and Amended Initial Pediatric Study
Plans.’’ This draft guidance is intended
to provide information to sponsors
regarding the submission of an initial
pediatric study plan (iPSP) and any
amendments to the iPSP as required
under the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) as
amended by the Food and Drug
Administration Safety and Innovation
Act (FDASIA). This guidance revises the
draft guidance entitled ‘‘Pediatric Study
Plans: Content of and Process for
Submitting Initial Pediatric Study Plans
Lhorne on DSK5TPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
15:08 Mar 08, 2016
Jkt 238001
and Amended Pediatric Study Plans’’
issued July 15, 2013.
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 May 9, 2016.
ADDRESSES: You may submit comments
as follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2013–D–0814 for ‘‘Pediatric Study
Plans: Content of and Process for
Submitting Initial Pediatric Study Plans
and Amended Initial Pediatric Study
Plans; Draft Guidance for Industry;
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
Availability.’’ Received comments will
be placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on https://
www.regulations.gov. Submit both
copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
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, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002, or Office of Communication,
Outreach, and Development, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
3128, Silver Spring, MD 20993–0002.
E:\FR\FM\09MRN1.SGM
09MRN1
]]>Agencies
[Federal Register Volume 81, Number 46 (Wednesday, March 9, 2016)]
[Notices]
[Pages 12506-12508]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-05224]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-D-0712]
Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary
Disease, a Patient-Reported Outcome, for the Measurement of Severity of
Respiratory Symptoms in Stable Chronic Obstructive Pulmonary Disease:
Qualification for Exploratory Use; Draft Guidance for Industry;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Evaluating
Respiratory Symptoms in Chronic Obstructive Pulmonary Disease, a
Patient-Reported Outcome, for the Measurement of Severity of
Respiratory Symptoms in Stable Chronic Obstructive Pulmonary Disease:
Qualification for Exploratory Use.'' This draft guidance provides a
statement of qualification for exploratory use for the evaluating
respiratory symptoms in chronic obstructive pulmonary disease (E-RS:
COPD), a 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
[[Page 12507]]
and Research's (CDER's) drug development tool (DDT) qualification
program. Qualification for exploratory use of the E-RS: COPD 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 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 June 7, 2016.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2016-D-0712 for ``Evaluating Respiratory Symptoms in Chronic
Obstructive Pulmonary Disease, a Patient-Reported Outcome, for the
Measurement of Severity of Respiratory Symptoms in Stable Chronic
Obstructive Pulmonary Disease: Qualification for Exploratory Use; Draft
Guidance for Industry; Availability.'' Received comments will be placed
in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
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, 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 draft guidance document.
FOR FURTHER INFORMATION CONTACT: Elektra Papadopoulos, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6377, Silver Spring, MD 20993-0002, 301-
796-0900.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Evaluating Respiratory Symptoms in Chronic Obstructive
Pulmonary Disease, a Patient-Reported Outcome, for the Measurement of
Severity of Respiratory Symptoms in Stable Chronic Obstructive
Pulmonary Disease: Qualification for Exploratory Use.''
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
[[Page 12508]]
describing the concept of interest and COU for which the tool is
qualified. This draft guidance describes the qualification statement
for the E-RS: COPD, 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 current thinking of FDA on the
qualification for exploratory use of the E-RS: COPD. It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.
II. Electronic Access
Persons with access to the Internet may obtain the draft guidance
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.
Dated: March 2, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-05224 Filed 3-8-16; 8:45 am]
BILLING CODE 4164-01-P
