81 FR 12506 - 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of Severity of Respiratory Symptoms in Stable Chronic Obstructive Pulmonary Disease: Qualification for Exploratory Use; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 46 (March 9, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 46 (March 9, 2016)
| Page Range | 12506-12508 | |
| FR Document | 2016-05224 |
[Federal Register Volume 81, Number 46 (Wednesday, March 9, 2016)] [Notices] [Pages 12506-12508] From the Federal Register Online [www.thefederalregister.org] [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of Severity of Respiratory Symptoms in Stable Chronic Obstructive Pulmonary Disease: Qualification for Exploratory Use; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease, a Patient-Reported Outcome, for the Measurement of Severity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 This draft guidance provides a statement of qualification for exploratory use for the evaluating respiratory symptoms in chronic obstructive pulmonary disease (E-RS: COPD), a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 This draft guidance is an attachment to the guidance for industry entitled ``Qualification Process for Drug Development Tools.''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: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://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 http://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 http://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: http://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 http://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 http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://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
![12506 Federal Register / Vol. 81, No. 46 / Wednesday, March 9, 2016 / Notices
regarding the salience of information in Pretesting will take place before the experiences may not reflect those of the
text. The questionnaire is available main study to select super sizes for the average consumer. We conducted a
upon request. Participation is estimated main study and to evaluate the priori power analyses to determine
to take approximately 20 minutes. procedures and measures that will be sample sizes for the pretest and the
To examine differences between used. We will exclude individuals who main study.
experimental conditions, we will work in health care or marketing
conduct inferential statistical tests such FDA estimates the burden of this
settings because their knowledge and collection of information as follows:
as analysis of variance.
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Number of Total annual Average burden per
Activity responses per Total hours
respondents responses response
respondent
Pretesting
No. to complete the screener (assumes 50% eli- 338 1 338 0.08 (5 minutes) ............ 27
gible).
No. of completes .................................................. 240 1 240 0.33 (20 minutes) .......... 79
Main Study
No. to complete the screener (assumes 50% eli- 1,785 1 1,785 0.08 (5 minutes) ............ 143
gible).
No. of completes .................................................. 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.
IV. References 9. Hill, A. and L. Scharff, ‘‘Readability of DEPARTMENT OF HEALTH AND
Computer Displays as a Function of HUMAN SERVICES
1. Hall, R.H. and P. Hanna, ‘‘The Impact of
Colour, Saturation, and Background
Web page Text-Background Colour
Combinations on Readability, Retention, Texture.’’ In: D. Harns (Ed.) Engineering Food and Drug Administration
Aesthetics and Behavioural Intention,’’ Psychology and Cognitive Ergonomics,
[Docket No. FDA–2016–D–0712]
Behaviour & Information Technology, (Vol. 4) Ashgate, Aldershot, United
2004;23:183–195. Kingdom. Evaluating Respiratory Symptoms in
2. Baur, C. and C. Prue, ‘‘The CDC Clear 10. Shieh, K.-K. and C.-C. Lin, ‘‘Effects of
Communication Index Is a New
Chronic Obstructive Pulmonary
Screen Type, Ambient Illumination, and
Evidence-Based Tool to Prepare and Disease, a Patient-Reported Outcome,
Color Combination on VDT Visual
Review Health Information,’’ Health for the Measurement of Severity of
Performance and Subjective Preference,’’
Promotion Practice, 2014;15:629–637. Respiratory Symptoms in Stable
3. Shrank, W., J. Avorn, C. Rolon, et al., International Journal of Industrial
Chronic Obstructive Pulmonary
‘‘Effect of Content and Format of Ergonomics, 2000;26:527–536.
Disease: Qualification for Exploratory
Prescription Drug Labels on Readability, 11. Tinker, M.A. and D.G. Paterson, ‘‘Studies
Use; Draft Guidance for Industry;
Understanding, and Medication Use: A of Typographical Factors Influencing
Systematic Review,’’ The Annals of
Availability
Speed of Reading. VII. Variations in
Pharmacotherapy, 2007;41:783–801. Color of Print and Background,’’ Journal AGENCY: Food and Drug Administration,
4. Wogalter, M.S. and W.J. Vigilante, Jr., of Applied Psychology, 1931;15:471–479. HHS.
‘‘Effects of Label Format on Knowledge 12. Legge, G.E., G.S. Rubin, and A. Luebner,
Acquisition and Perceived Readability ACTION: Notice of availability.
‘‘Psychophysics of Reading—V. The Role
by Younger and Older Adults,’’
Ergonomics, 2003;46:327–344. of Contrast in Normal Vision,’’ Vision SUMMARY: The Food and Drug
5. Smither, J.A.A. and C.C. Braun, Research, 1987;27:1165–1177. Administration (FDA or Agency) is
‘‘Readability of Prescription Drug Labels 13. Kaufman, D.W., J.P. Kelly, L. Rosenberg, announcing the availability of a draft
by Older and Younger Adults,’’ Journal et al., ‘‘Recent Patterns of Medication guidance for industry entitled
of Clinical Psychology in Medicine Use in the Ambulatory Adult Population ‘‘Evaluating Respiratory Symptoms in
Settings, 1994;1:149–159. of the United States: The Slone Survey,’’ Chronic Obstructive Pulmonary Disease,
6. Foxman, E.R., D.D. Muehling, and P.A. The Journal of the American Medical a Patient-Reported Outcome, for the
Moore, ‘‘Disclaimer Footnotes in Ads: Association, 2002;287:337–344.
Discrepancies Between Purpose and
Measurement of Severity of Respiratory
Performance,’’ Journal of Public Policy & Dated: March 2, 2016. Symptoms in Stable Chronic
Marketing, 1988;7:127–137. Leslie Kux,
Obstructive Pulmonary Disease:
7. Murray, N.M., L.A. Manrai, and A.K. Qualification for Exploratory Use.’’ This
Manrai, ‘‘Public Policy Relating to Associate Commissioner for Policy. draft guidance provides a statement of
Consumer Comprehension of Television [FR Doc. 2016–05233 Filed 3–8–16; 8:45 am] qualification for exploratory use for the
Lhorne on DSK5TPTVN1PROD with NOTICES
Commercials: A Review and Some BILLING CODE 4164–01–P evaluating respiratory symptoms in
Empirical Results,’’ Journal of Consumer chronic obstructive pulmonary disease
Policy, 1993;16:145–170.
8. Manrai, L.A., A.K. Manrai, and N. Murray,
(E–RS: COPD), a patient-reported
‘‘Comprehension of Info-Aid Supers in outcome instrument, and summarizes
Television Advertising for Social Ideas: the concept of interest and context of
Implications for Public Policy,’’ Journal use (COU) for which the tool is qualified
of Business Research, 1994;30:75–84. through the Center for Drug Evaluation
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describing the concept of interest and and Amended Pediatric Study Plans’’ Availability.’’ Received comments will
COU for which the tool is qualified. issued July 15, 2013. be placed in the docket and, except for
This draft guidance describes the DATES: Although you can comment on those submitted as ‘‘Confidential
qualification statement for the E–RS: any guidance at any time (see 21 CFR Submissions,’’ publicly viewable at
COPD, a COA DDT. 10.115(g)(5)), to ensure that the Agency http://www.regulations.gov or at the
This draft guidance is being issued considers your comment on this draft Division of Dockets Management
consistent with FDA’s good guidance guidance before it begins work on the between 9 a.m. and 4 p.m., Monday
practices regulation (21 CFR 10.115). final version of the guidance, submit through Friday.
The draft guidance, when finalized, will either electronic or written comments • Confidential Submissions—To
represent the current thinking of FDA on the draft guidance by May 9, 2016. submit a comment with confidential
on the qualification for exploratory use information that you do not wish to be
ADDRESSES: You may submit comments
of the E–RS: COPD. It does not establish made publicly available, submit your
as follows: comments only as a written/paper
any rights for any person and is not
binding on FDA or the public. You can Electronic Submissions submission. You should submit two
use an alternative approach if it satisfies copies total. One copy will include the
Submit electronic comments in the
the requirements of the applicable information you claim to be confidential
following way:
statutes and regulations. with a heading or cover note that states
• Federal eRulemaking Portal: http://
‘‘THIS DOCUMENT CONTAINS
II. Electronic Access www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The
instructions for submitting comments. Agency will review this copy, including
Persons with access to the Internet Comments submitted electronically,
may obtain the draft guidance at either the claimed confidential information, in
including attachments, to http:// its consideration of comments. The
http://www.fda.gov/Drugs/Guidance www.regulations.gov will be posted to
ComplianceRegulatoryInformation/ second copy, which will have the
the docket unchanged. Because your claimed confidential information
Guidances/default.htm or http:// comment will be made public, you are
www.regulations.gov. redacted/blacked out, will be available
solely responsible for ensuring that your for public viewing and posted on http://
Dated: March 2, 2016. comment does not include any www.regulations.gov. Submit both
Leslie Kux, confidential information that you or a copies to the Division of Dockets
Associate Commissioner for Policy. third party may not wish to be posted, Management. If you do not wish your
[FR Doc. 2016–05224 Filed 3–8–16; 8:45 am] such as medical information, your or name and contact information to be
BILLING CODE 4164–01–P
anyone else’s Social Security number, or made publicly available, you can
confidential business information, such provide this information on the cover
as a manufacturing process. Please note sheet and not in the body of your
DEPARTMENT OF HEALTH AND that if you include your name, contact comments and you must identify this
HUMAN SERVICES information, or other information that information as ‘‘confidential.’’ Any
identifies you in the body of your information marked as ‘‘confidential’’
Food and Drug Administration comments, that information will be will not be disclosed except in
posted on http://www.regulations.gov. accordance with 21 CFR 10.20 and other
[Docket No. FDA–2013–D–0814]
• If you want to submit a comment applicable disclosure law. For more
Pediatric Study Plans: Content of and with confidential information that you information about FDA’s posting of
Process for Submitting Initial Pediatric do not wish to be made available to the comments to public dockets, see 80 FR
Study Plans and Amended Initial public, submit the comment as a 56469, September 18, 2015, or access
Pediatric Study Plans; Draft Guidance written/paper submission and in the the information at: http://www.fda.gov/
for Industry; Availability manner detailed (see ‘‘Written/Paper regulatoryinformation/dockets/
Submissions’’ and ‘‘Instructions’’). default.htm.
AGENCY: Food and Drug Administration, Docket: For access to the docket to
Written/Paper Submissions
HHS. read background documents or the
ACTION: Notice of availability. Submit written/paper submissions as electronic and written/paper comments
follows: received, go to http://
SUMMARY: The Food and Drug • Mail/Hand delivery/Courier (for www.regulations.gov and insert the
Administration (FDA or Agency) is written/paper submissions): Division of docket number, found in brackets in the
announcing the availability of a draft Dockets Management (HFA–305), Food heading of this document, into the
guidance for industry entitled ‘‘Pediatric and Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts
Study Plans: Content of and Process for Lane, Rm. 1061, Rockville, MD 20852. and/or go to the Division of Dockets
Submitting Initial Pediatric Study Plans • For written/paper comments Management, 5630 Fishers Lane, Rm.
and Amended Initial Pediatric Study submitted to the Division of Dockets 1061, Rockville, MD 20852.
Plans.’’ This draft guidance is intended Management, FDA will post your Submit written requests for single
to provide information to sponsors comment, as well as any attachments, copies of the draft guidance to the
regarding the submission of an initial except for information submitted, Division of Drug Information, Center for
pediatric study plan (iPSP) and any marked and identified, as confidential, Drug Evaluation and Research, Food
amendments to the iPSP as required if submitted as detailed in and Drug Administration, 10001 New
under the Federal Food, Drug, and ‘‘Instructions.’’ Hampshire Ave., Hillandale Building,
Lhorne on DSK5TPTVN1PROD with NOTICES
Cosmetic Act (the FD&C Act) as Instructions: All submissions received 4th Floor, Silver Spring, MD 20993–
amended by the Food and Drug must include the Docket No. FDA– 0002, or Office of Communication,
Administration Safety and Innovation 2013–D–0814 for ‘‘Pediatric Study Outreach, and Development, Center for
Act (FDASIA). This guidance revises the Plans: Content of and Process for Biologics Evaluation and Research,
draft guidance entitled ‘‘Pediatric Study Submitting Initial Pediatric Study Plans Food and Drug Administration, 10903
Plans: Content of and Process for and Amended Initial Pediatric Study New Hampshire Ave., Bldg. 71, Rm.
Submitting Initial Pediatric Study Plans Plans; Draft Guidance for Industry; 3128, Silver Spring, MD 20993–0002.
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Document Created: 2016-03-09 00:13:13
Document Modified: 2016-03-09 00:13:13
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| 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. | |
| 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. | |
| FR Citation | 81 FR 12506 |
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