83 FR 27618 - Patient-Focused Drug Development: Collecting Comprehensive and Representative Input; Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 114 (June 13, 2018)

Page Range		27618-27619
FR Document		2018-12636

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry, FDA staff, and other stakeholders entitled ``Patient-Focused Drug Development: Collecting Comprehensive and Representative Input.'' This guidance (Guidance 1) is the first of a series of four methodological guidance documents that FDA committed to develop to address in a stepwise manner how to collect and submit information from patients and caregivers for medical product development and regulatory decision making.

Federal Register, Volume 83 Issue 114 (Wednesday, June 13, 2018)

[Federal Register Volume 83, Number 114 (Wednesday, June 13, 2018)]
[Notices]
[Pages 27618-27619]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-12636]



[[Page 27618]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1893]


Patient-Focused Drug Development: Collecting Comprehensive and 
Representative Input; Draft Guidance for Industry, Food and Drug 
Administration Staff, and Other Stakeholders; 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the availability of a draft guidance for industry, FDA staff, and other 
stakeholders entitled ``Patient-Focused Drug Development: Collecting 
Comprehensive and Representative Input.'' This guidance (Guidance 1) is 
the first of a series of four methodological guidance documents that 
FDA committed to develop to address in a stepwise manner how to collect 
and submit information from patients and caregivers for medical product 
development and regulatory decision making.

DATES: Submit either electronic or written comments on the draft 
guidance by September 11, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time 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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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-2018-D-1893 for ``Patient-Focused Drug Development: Collecting 
Comprehensive and Representative Input; Draft Guidance for Industry, 
Food and Drug Administration Staff, and Other Stakeholders; 
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 Dockets Management 
Staff 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 Dockets Management Staff. 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.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    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: Meghana Chalasani, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 1146, Silver Spring, MD 20993-0002, 240-
402-6525, Fax: 301-847-8443, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing availability of a draft guidance for industry, 
FDA staff, and other stakeholders entitled ``Patient-Focused Drug 
Development: Collecting Comprehensive and Representative Input.'' This 
guidance (Guidance 1) is the first of a series of four guidance 
documents that FDA committed to develop to address in a stepwise manner 
how stakeholders (patients, researchers, medical product developers, 
and others) can collect and submit information from patients and 
caregivers for medical product development and regulatory decision 
making. This series of guidance documents is intended to facilitate the 
advancement and use of systematic approaches to collect and use robust 
and meaningful patient and caregiver input that can more consistently 
inform medical product development and regulatory decision making. The 
purpose of Guidance 1 is to present methods for collecting information 
on the patient experience that is representative of the intended 
population to inform the development and evaluation of medical products

[[Page 27619]]

throughout the medical product lifecycle. In addition, this document 
discusses methods on how to operationalize and standardize the 
collection, analysis, and dissemination of patient experience data. 
Guidance 1 also includes a glossary of terms that will be used in one 
or more of the series of four guidance documents.
    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 ``Patient-
Focused Drug Development: Collecting Comprehensive and Representative 
Input.'' 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. 
This guidance is not subject to Executive Order 12866.

II. Additional Information

    Section 3002 of Title III, Subtitle A of the 21st Century Cures Act 
(Pub. L. 114-255) directs FDA to develop patient-focused drug 
development guidance to address a number of areas, including under 
section 3002(c)(1) (methodological approaches), which are relevant and 
objective and ensure that such data are accurate and representative of 
the intended population, that a person seeking to collect patient 
experience data to inform regulatory decision making may use.
    In addition, FDA committed to meet certain performance goals under 
the sixth authorization of the Prescription Drug User Fee Act. These 
goal commitments were developed in consultation with patient and 
consumer advocates, healthcare professionals, and other public 
stakeholders, as part of negotiations with regulated industry. Section 
I.J.1. of the commitment letter, ``Enhancing the Incorporation of the 
Patient's Voice in Drug Development and Decision-Making,'' (https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM511438.pdf) outlines work, including the development of a series of 
guidance documents and associated public workshops to facilitate the 
advancement and use of systematic approaches to collect and utilize 
robust and meaningful patient and caregiver input that can more 
consistently inform drug development, and, as appropriate, regulatory 
decision making.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.

    Dated: June 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12636 Filed 6-12-18; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 114 / Wednesday, June 13, 2018 / Notices 27619

throughout the medical product ComplianceRegulatoryInformation/ The Subcommittee on Harmonization
lifecycle. In addition, this document Guidances/default.htm or https:// (SOH) was established by SACHRP at its
discusses methods on how to www.regulations.gov. July 2009 meeting and charged with
operationalize and standardize the Dated: June 7, 2018. identifying and prioritizing areas in
collection, analysis, and dissemination Leslie Kux,
which regulations and/or guidelines for
of patient experience data. Guidance 1 human subjects research adopted by
Associate Commissioner for Policy.
also includes a glossary of terms that various agencies or offices within HHS
will be used in one or more of the series [FR Doc. 2018–12636 Filed 6–12–18; 8:45 am]
would benefit from harmonization,
of four guidance documents. BILLING CODE 4164–01–P consistency, clarity, simplification and/
This draft guidance is being issued or coordination.
consistent with FDA’s good guidance The SACHRP meeting will open to the
practices regulation (21 CFR 10.115). DEPARTMENT OF HEALTH AND
HUMAN SERVICES public at 8:30 a.m., on Tuesday, July 10,
The draft guidance, when finalized, will 2018, followed by opening remarks from
represent the current thinking of FDA Dr. Jerry Menikoff, Director of OHRP
Meeting of the Secretary’s Advisory
on ‘‘Patient-Focused Drug Development: and Dr. Stephen Rosenfeld, SACHRP
Committee on Human Research
Collecting Comprehensive and Chair.
Representative Input.’’ It does not Protections
The SAS and SOH subcommittees
establish any rights for any person and AGENCY: Office of the Assistant will present their recommendations
is not binding on FDA or the public. Secretary for Health, Office of the regarding the description of ‘‘key
You can use an alternative approach if Secretary, Department of Health and information,’’ as required by the revised
it satisfies the requirements of the Human Services. Common Rule at § 46.116(a)(5)(i). This
applicable statutes and regulations. This ACTION: Notice. will be followed by a discussion of the
guidance is not subject to Executive
Pursuant to Section 10(a) of application of the revised Common
Order 12866. SUMMARY:
the Federal Advisory Committee Act, Rule’s exemptions at 46.104(d) to FDA-
II. Additional Information regulated research, and
U.S.C. Appendix 2, notice is hereby
Section 3002 of Title III, Subtitle A of given that the Secretary’s Advisory recommendations on the interpretation
the 21st Century Cures Act (Pub. L. 114– Committee on Human Research of § 46.104(d)(1) and (2) for HHS funded
255) directs FDA to develop patient- Protections (SACHRP) will hold a research.
focused drug development guidance to meeting that will be open to the public. The Wednesday, July 11, meeting will
address a number of areas, including Information about SACHRP and the full begin at 8:30 a.m. The SAS
under section 3002(c)(1) meeting agenda will be posted on the subcommittee will present and discuss
(methodological approaches), which are SACHRP website at: http:// recommendations on the interpretation
relevant and objective and ensure that www.dhhs.gov/ohrp/sachrp-committee/ of ‘‘reasonably available’’ at § 46.408(b),
such data are accurate and meetings/index.html. as well as discuss issues surrounding
representative of the intended payment to subjects for participation in
DATES: The meeting will be held on
population, that a person seeking to research. Modifications to the previous
Tuesday, July 10, 2018, from 8:30 a.m.
collect patient experience data to inform day’s work will be discussed and
until 5:00 p.m., and Wednesday, July
regulatory decision making may use. finalized. The meeting will adjourn at
11, 2018, from 8:30 a.m. until 4:00 p.m.
In addition, FDA committed to meet approximately 4:00 p.m., July 11, 2018.
ADDRESSES: 6001 Executive Boulevard,
certain performance goals under the Time for public comment sessions
sixth authorization of the Prescription Conference Room A, Rockville,
will be allotted both days. On-site
Drug User Fee Act. These goal Maryland 20852.
registration is required for participation
commitments were developed in FOR FURTHER INFORMATION CONTACT: Julia
in the live public comment session.
consultation with patient and consumer Gorey, J.D., Executive Director, Note that public comment must be
advocates, healthcare professionals, and SACHRP; U.S. Department of Health relevant to topics currently being
other public stakeholders, as part of and Human Services, 1101 Wootton addressed by the SACHRP. Individuals
negotiations with regulated industry. Parkway, Suite 200, Rockville, submitting written statements as public
Section I.J.1. of the commitment letter, Maryland 20852; telephone: 240–453– comment should provide their
‘‘Enhancing the Incorporation of the 8141; fax: 240–453–6909; email address: comments by email to SACHRP@
Patient’s Voice in Drug Development SACHRP@hhs.gov. hhs.gov or by fax to (240) 453–6909 at
and Decision-Making,’’ (https:// SUPPLEMENTARY INFORMATION: Under the least five business days prior to the
www.fda.gov/downloads/ForIndustry/ authority of 42 U.S.C. 217a, Section 222 meeting.
UserFees/PrescriptionDrugUserFee/ of the Public Health Service Act, as Public attendance at the meeting is
UCM511438.pdf) outlines work, amended, SACHRP was established to limited to space available. Individuals
including the development of a series of provide expert advice and who plan to attend and need special
guidance documents and associated recommendations to the Secretary of assistance, such as sign language
public workshops to facilitate the Health and Human Services, through interpretation or other reasonable
advancement and use of systematic the Assistant Secretary for Health, on accommodations, should notify the
approaches to collect and utilize robust issues and topics pertaining to or designated SACHRP point of contact at
and meaningful patient and caregiver associated with the protection of human the address/phone number listed above
input that can more consistently inform research subjects.
amozie on DSK3GDR082PROD with NOTICES1

at least one week prior to the meeting.
drug development, and, as appropriate, The Subpart A Subcommittee (SAS)
was established by SACHRP in October Dated: June 7, 2018.
regulatory decision making.
2006 and is charged with developing Julia G. Gorey,
III. Electronic Access recommendations for consideration by Executive Director, Secretary’s Advisory
Persons with access to the internet SACHRP regarding the application of Committee on Human Research Protections.
may obtain the draft guidance at http:// subpart A of 45 CFR part 46 in the [FR Doc. 2018–12662 Filed 6–12–18; 8:45 am]
www.fda.gov/Drugs/Guidance current research environment. BILLING CODE 4150–36–P

VerDate Sep<11>2014 18:01 Jun 12, 2018 Jkt 244001 PO 00000 Frm 00082 Fmt 4703 Sfmt 4703 E:\FR\FM\13JNN1.SGM 13JNN1

Document Created: 2018-06-12 23:59:17
Document Modified: 2018-06-12 23:59:17

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		Submit either electronic or written comments on the draft guidance by September 11, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
Contact		Meghana Chalasani, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1146, Silver Spring, MD 20993-0002, 240- 402-6525, Fax: 301-847-8443, [email protected]
FR Citation		83 FR 27618

83 FR 27618 - Patient-Focused Drug Development: Collecting Comprehensive and Representative Input; Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 114 (June 13, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration