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This draft guidance is being issued 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The draft guidance, when finalized, will 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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