27618 Federal Register / Vol. 83, No. 114 / Wednesday, June 13, 2018 / Notices 

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Representative Input; Draft Guidance 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 ‘‘PatientFocused 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written comments on the draft guidance 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this draft guidance before it begins work 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.gpo.gov/ 

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, 

Meghana.Chalasani@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing availability of a 

draft guidance for industry, FDA staff, 

and other stakeholders entitled ‘‘PatientFocused 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 


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

ComplianceRegulatoryInformation/

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] 

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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Meeting of the Secretary’s Advisory 

Committee on Human Research 

Protections 

AGENCY: Office of the Assistant 

Secretary for Health, Office of the 

Secretary, Department of Health and 

Human Services. 

ACTION: Notice. 

SUMMARY: Pursuant to Section 10(a) of 

the Federal Advisory Committee Act, 

U.S.C. Appendix 2, notice is hereby 

given that the Secretary’s Advisory 

Committee on Human Research 

Protections (SACHRP) will hold a 

meeting that will be open to the public. 

Information about SACHRP and the full 

meeting agenda will be posted on the 

SACHRP website at: http://

www.dhhs.gov/ohrp/sachrp-committee/ 

meetings/index.html. 

DATES: The meeting will be held on 

Tuesday, July 10, 2018, from 8:30 a.m. 

until 5:00 p.m., and Wednesday, July 

11, 2018, from 8:30 a.m. until 4:00 p.m. 

ADDRESSES: 6001 Executive Boulevard, 

Conference Room A, Rockville, 

Maryland 20852. 

FOR FURTHER INFORMATION CONTACT: Julia 

Gorey, J.D., Executive Director, 

SACHRP; U.S. Department of Health 

and Human Services, 1101 Wootton 

Parkway, Suite 200, Rockville, 

Maryland 20852; telephone: 240–453– 

8141; fax: 240–453–6909; email address: 

SACHRP@hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

authority of 42 U.S.C. 217a, Section 222 

of the Public Health Service Act, as 

amended, SACHRP was established to 

provide expert advice and 

recommendations to the Secretary of 

Health and Human Services, through 

the Assistant Secretary for Health, on 

issues and topics pertaining to or 

associated with the protection of human 

research subjects. 

The Subpart A Subcommittee (SAS) 

was established by SACHRP in October 

2006 and is charged with developing 

recommendations for consideration by 

SACHRP regarding the application of 

subpart A of 45 CFR part 46 in the 

current research environment. 

The Subcommittee on Harmonization 

(SOH) was established by SACHRP at its 

July 2009 meeting and charged with 

identifying and prioritizing areas in 

which regulations and/or guidelines for 

human subjects research adopted by 

various agencies or offices within HHS 

would benefit from harmonization, 

consistency, clarity, simplification and/ 

or coordination. 

The SACHRP meeting will open to the 

public at 8:30 a.m., on Tuesday, July 10, 

2018, followed by opening remarks from 

Dr. Jerry Menikoff, Director of OHRP 

and Dr. Stephen Rosenfeld, SACHRP 

Chair. 

The SAS and SOH subcommittees 

will present their recommendations 

regarding the description of ‘‘key 

information,’’ as required by the revised 

Common Rule at § 46.116(a)(5)(i). This 

will be followed by a discussion of the 

application of the revised Common 

Rule’s exemptions at 46.104(d) to FDAregulated research, and 

recommendations on the interpretation 

of § 46.104(d)(1) and (2) for HHS funded 

research. 

The Wednesday, July 11, meeting will 

begin at 8:30 a.m. The SAS 

subcommittee will present and discuss 

recommendations on the interpretation 

of ‘‘reasonably available’’ at § 46.408(b), 

as well as discuss issues surrounding 

payment to subjects for participation in 

research. Modifications to the previous 

day’s work will be discussed and 

finalized. The meeting will adjourn at 

approximately 4:00 p.m., July 11, 2018. 

Time for public comment sessions 

will be allotted both days. On-site 

registration is required for participation 

in the live public comment session. 

Note that public comment must be 

relevant to topics currently being 

addressed by the SACHRP. Individuals 

submitting written statements as public 

comment should provide their 

comments by email to SACHRP@

hhs.gov or by fax to (240) 453–6909 at 

least five business days prior to the 

meeting. 

Public attendance at the meeting is 

limited to space available. Individuals 

who plan to attend and need special 

assistance, such as sign language 

interpretation or other reasonable 

accommodations, should notify the 

designated SACHRP point of contact at 

the address/phone number listed above 

at least one week prior to the meeting. 

Dated: June 7, 2018. 

Julia G. Gorey, 

Executive Director, Secretary’s Advisory 

Committee on Human Research Protections. 

[FR Doc. 2018–12662 Filed 6–12–18; 8:45 am] 

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