83_FR_27733 83 FR 27619 - Meeting of the Secretary's Advisory Committee on Human Research Protections

83 FR 27619 - Meeting of the Secretary's Advisory Committee on Human Research Protections

DEPARTMENT OF HEALTH AND HUMAN SERVICES

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

Page Range27619-27619
FR Document2018-12662

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.

Federal Register, Volume 83 Issue 114 (Wednesday, June 13, 2018) 
[Federal Register Volume 83, Number 114 (Wednesday, June 13, 2018)]
[Notices]
[Page 27619]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-12662]


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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.

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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: [email protected].

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 Sec.  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 FDA-regulated research, and recommendations on the 
interpretation of Sec.  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 Sec.  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 
[email protected] 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]
BILLING CODE 4150-36-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 23:59:25
Document Modified: 2018-06-12 23:59:25
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesThe 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.
ContactJulia 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;
FR Citation83 FR 27619 
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