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and the FDA draft guidance document 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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