Federal Register / Vol. 80, No. 45 / Monday, March 9, 2015 / Notices 12497 

Ave., Bldg. 32, Rm. 5103, Silver Spring, 

MD 20993–0002; or the Office of 

Communication, Outreach and 

Development, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

Silver Spring, MD 20993–0002; or the 

Division of Small Manufacturers, 

International, and Consumer Assistance, 

Center for Devices and Radiological 

Health, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 66, 

Rm. 4613, 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access to the draft guidance document. 

Submit electronic comments on the 

draft guidance to http://

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Cheryl Grandinetti, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6316, 

Silver Spring, MD 20993–0002, 301– 

796–2500; Patrick McNeilly, Office of 

the Commissioner, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 5103, Silver Spring, 

MD 20993, 301–796–8340; Stephen 

Ripley, Center for Biologics Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 71, Rm. 7301, Silver Spring, 

MD 20993–0002, 1–800–835–4709 or 

301–827–6210; or Irfan Khan, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, Rm. 3459, 

Silver Spring, MD 20993, 1–800–638– 

2041 or 301–796–7100. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry, clinical 

investigators, and institutional review 

boards entitled ‘‘Use of Electronic 

Informed Consent in Clinical 

Investigations: Questions and Answers.’’ 

This guidance provides 

recommendations for clinical 

investigators, study sponsors, and IRBs 

on the use of electronic media and 

processes to obtain informed consent for 

FDA-regulated clinical investigations of 

medical products, including human 

drug and biological products, medical 

devices, and combinations thereof. In 

particular, the guidance provides 

recommendations on procedures that 

may be followed when using an 

electronic informed consent (eIC) to 

help (1) ensure protection of the rights, 

safety, and welfare of human subjects; 

(2) ensure the subject’s comprehension 

of the information presented during the 

eIC process; (3) ensure that appropriate 

documentation of consent is obtained 

when electronic media and processes 

are used to obtain informed consent; 

and (4) ensure the quality and integrity 

of eIC data included in FDA application 

submissions or made available to FDA 

during inspections. 

To enhance human subject protection 

and reduce regulatory burden, the 

Department of Health and Human 

Services, Office for Human Research 

Protections, and FDA have been actively 

working to harmonize the Agencies’ 

regulatory requirements and guidance 

for human subject research. This 

guidance document was developed as a 

part of these efforts. 

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 Agency’s current thinking 

on the use of eIC in investigational 

studies. It does not create or confer any 

rights for or on any person and does not 

operate to bind FDA or the public. An 

alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. The Paperwork Reduction Act of 

1995 

This draft guidance refers to 

previously approved collections of 

information found in FDA regulations. 

These collections of information are 

subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The collections 

of information in 21 CFR part 11 related 

to electronic records; electronic 

signatures have been approved under 

OMB control number 0910–0303; 21 

CFR parts 50 and 56 related to 

protection of human subjects; IRBs have 

been approved under OMB control 

number 0910–0755; 21 CFR 56.115 

related to IRB recordkeeping 

requirements, which include the 

requirements for records related to 

informed consent, have been approved 

under OMB control number 0910–0130; 

the collections of information in 21 CFR 

part 312 have been approved under 

OMB control number 0910–0014; and 

the collections of information in 21 CFR 

part 812 have been approved under 

OMB control number 0910–0078. 

III. Comments 

Interested persons may submit either 

electronic comments regarding this 

document to http://www.regulations.gov 

or written comments to the Division of 

Dockets Management (see ADDRESSES). It 

is only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday, and 

will be posted to the docket at http://

www.regulations.gov. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at http://

www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm; http://

www.fda.gov/BiologicsBloodVaccines/

GuidanceComplianceRegulatory

Information/Guidances/default.htm; 

http://www.fda.gov/MedicalDevices/

DeviceRegulationandGuidance/

GuidanceDocuments/default.htm; or 

http://www.regulations.gov. 

Dated: March 3, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–05377 Filed 3–6–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Draft Guidance for Industry, Clinical 

Investigators, and Institutional Review 

Boards—Use of an Electronic Informed 

Consent in Clinical Investigations— 

Questions and Answers; Availability 

AGENCY: Office for Human Research 

Protections, Office of the Assistant 

Secretary for Health, Office of the 

Secretary, Department of Health and 

Human Services. 

ACTION: Notice. 

SUMMARY: In this issue of the Federal 

Register, the Food and Drug 

Administration (FDA) is announcing the 

availability of draft guidance for 

industry, clinical investigators, and 

institutional review boards entitled 

‘‘Use of Electronic Informed Consent in 

Clinical Investigations—Questions and 

Answers.’’ The draft guidance provides 

recommendations for clinical 

investigators, sponsors, and institutional 

review boards (IRBs) on the use of 

electronic media and processes to obtain 

informed consent for FDA-regulated 

clinical investigations of medical 

products, including human drug and 

mstockstill on DSK4VPTVN1PROD with NOTICES

12498 Federal Register / Vol. 80, No. 45 / Monday, March 9, 2015 / Notices 

biological products, medical devices, 

and combinations thereof. 

To enhance human subject protection 

and reduce regulatory burden, the 

Department of Health and Human 

Services Office for Human Research 

Protections (OHRP) and FDA have been 

actively working to harmonize the 

agencies’ regulatory requirements and 

guidance for human subject research, 

and the FDA draft guidance document 

was developed as a part of these efforts. 

Although the document is issued by 

FDA and is drafted as guidance that 

would apply to FDA-regulated clinical 

investigations, OHRP is considering 

whether to adopt the positions and 

recommendations proposed in this 

guidance for research regulated under 

the HHS protection of human subjects 

regulations, 45 CFR part 46, and to issue 

a joint OHRP and FDA guidance 

document on this topic when the final 

guidance document is developed. OHRP 

asks for public comment about whether 

a joint guidance document would be 

useful for the regulated community. In 

particular, OHRP is interested in public 

comment regarding whether FDA’s draft 

guidance would be appropriate for all 

research regulated under 45 CFR part 

46, including research studies other 

than clinical investigations or clinical 

trials, such as social and behavioral 

research studies. If different guidance 

should apply to social and behavioral 

research, or other non-FDA-regulated 

studies, OHRP asks that the public 

comments address how the guidance 

should differ from the proposed 

guidance for FDA-regulated clinical 

investigations. 

OHRP specifically welcomes feedback 

regarding when it might or might not be 

appropriate, for studies other than 

clinical trials, for OHRP to recommend 

that researchers verify that the person 

signing the informed consent form is the 

subject participating in the research. 

OHRP and FDA will consider these 

comments in deciding whether to issue 

a joint OHRP/FDA guidance document 

on this topic when the final guidance 

document is developed. 

DATES: May 7, 2015. 

ADDRESSES: You may submit comments 

identified by docket ID number HHS– 

OPHS–2015–0002 by one of the 

following methods: 

Federal eRulemaking Portal: http://

www.regulations.gov. Enter the above 

docket ID number in the Enter Keyword 

or ID field and click on ‘‘Search.’’ On 

the next page, click the ‘‘Submit a 

Comment’’ action and follow the 

instructions. 

Mail/Hand delivery/Courier [For 

paper, disk, or CD–ROM submissions] 

to: Irene Stith-Coleman, Ph.D., Office for 

Human Research Protections, 1101 

Wootton Parkway, Suite 200, Rockville, 

MD 20852. 

Comments received, including any 

personal information, will be posted 

without change to http://

www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Irene Stith-Coleman, Office for Human 

Research Protections, Department of 

Health and Human Services, 1101 

Wootton Parkway, Suite 200, Rockville, 

MD 20852; phone 240–453–6900; email 

Irene.Stith-Coleman@hhs.gov. 

Dated: March 3, 2015. 

Jerry Menikoff, 

Director, Office for Human Research 

Protections. 

[FR Doc. 2015–05301 Filed 3–6–15; 8:45 am] 

BILLING CODE 4150–36–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Human Genome Research 

Institute; Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Human 

Genome Research Institute Special Emphasis 

Panel Loan Repayment Program. 

Date: April 30, 2015. 

Time: 1:00 p.m. to 3:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Human Genome Research 

Institute, 3rd Floor Conference Room, 5635 

Fishers Lane, Rockville, MD, (Telephone 

Conference Call). 

Contact Person: Keith McKenney, Ph.D., 

Scientific Review Officer, National Human 

Genome Research Institute, 5635 Fishers 

Lane, Suite 4076, Bethesda, MD 20814, 301– 

594–4280, mckenneyk@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.172, Human Genome 

Research, National Institutes of Health, HHS) 

Dated: March 3, 2015. 

David Clary, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2015–05305 Filed 3–6–15; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–0647] 

Complexities in Personalized 

Medicine: Harmonizing Companion 

Diagnostics Across a Class of 

Targeted Therapies; Public Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

The Food and Drug Administration 

(FDA), in co-sponsorship with the 

American Association for Cancer 

Research (AACR) and the American 

Society of Clinical Oncology (ASCO), is 

announcing a public workshop entitled 

‘‘Complexities in Personalized 

Medicine: Harmonizing Companion 

Diagnostics Across a Class of Targeted 

Therapies.’’ The objective of the 

workshop is to facilitate an in-depth 

discussion of harmonization of 

companion diagnostic devices across a 

class of targeted therapies. The 

workshop aims to foster collaborations 

in the clinical cancer research 

community; provide a deeper 

understanding of anticancer drug and 

device development related to 

personalized medicine; provide a 

unique perspective of personalized 

medicine; and help incorporate 

emerging scientific findings to 

harmonize companion diagnostics 

across a class of targeted therapies. 

Date and Time: The public workshop 

will be held on March 24, 2015, from 

8:30 a.m. to 4:30 p.m. 

Location: The public workshop will 

be held at the Mayflower Hotel, Grand 

Ballroom, 1127 Connecticut Ave. NW., 

Washington, DC 20036, 202–347–3000. 

Contact Persons: Kaitlyn Antonelli, 

American Society of Clinical Oncology, 

2318 Mill Rd., suite 800, Alexandria, 

VA 22314, 571–483–1606, 

Kaitlyn.Antonelli@asco.org; Pamela 

Bradley, Center for Devices and 

Radiological Health, Office of In Vitro 

Diagnostics and Radiological Health, 

Food and Drug Administration, 10903 

New Hampshire Ave., Silver Spring, MD 

20993–0002, 240–731–3734, 

Pamela.Bradley@fda.hhs.gov; and 

Rasika Kalamegham, American 

Association for Cancer Research, 1425 K 

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