17440 Federal Register / Vol. 80, No. 62 / Wednesday, April 1, 2015 / Notices 

general circumstances in which CDRH 

consults with a panel of the Medical 

Devices Advisory Committee, the 

process for exchange of information 

between CDRH, the members of the 

panel, industry, and the public, and the 

conduct of panel meetings. The Medical 

Devices Advisory Committee includes 

17 panels other than the DRP (Ref. 1). 

The panels, according to their specialty 

area and authorization, advise the 

Commissioner of Food and Drugs in 

discharging responsibilities as they 

relate to assuring the safety and 

effectiveness of medical devices, and as 

required, any other product for which 

FDA has regulatory responsibility. 

This draft guidance is intended to 

provide more comprehensive 

information for industry and for CDRH 

staff on the processes associated with a 

panel meeting held for any of the 

reasons identified in the guidance. Once 

final, this guidance will replace the 

‘‘Guidance on Amended Procedures for 

Advisory Panel Meetings’’ (Ref. 2) and 

the guidance document entitled ‘‘Panel 

Review of Premarket Approval 

Applications #P91–2 blue book memo’’ 

(Ref. 3). This guidance supplements 

existing FDA Agency-wide guidance on 

the conduct of Advisory Committee 

meetings. 

II. Significance of Guidance 

This draft guidance is being issued 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The draft guidance, when finalized, will 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 panel meeting process for 

medical devices. 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 statute 

and regulations. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the draft guidance may do so by 

downloading an electronic copy from 

the Internet. A search capability for all 

CDRH guidance documents is available 

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

DeviceRegulationandGuidance/

GuidanceDocuments/default.htm. 

Guidance documents are also available 

at http://www.regulations.gov. Persons 

unable to download an electronic copy 

of ‘‘Procedures for Meetings of the 

Medical Devices Advisory Committee’’ 

may send an email request to CDRHGuidance@fda.hhs.gov to receive an 

electronic copy of the document. Please 

use the document number 413 to 

identify the guidance you are 

requesting. 

IV. Paperwork Reduction Act of 1995 

This 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 807, subpart E have been 

approved under OMB control number 

0910–0120; the collections of 

information in 21 CFR part 860 have 

been approved under OMB control 

number 0910–0138; the collections of 

information in 21 CFR part 814 have 

been approved under OMB control 

number 0910–0231; and the collections 

of information in 21 CFR part 814, 

subpart H have been approved under 

OMB control number 0910–0332. 

V. 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. 

VI. References 

The following references have been 

placed on display in the Division of 

Dockets Management (see ADDRESSES), 

and may be seen by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday, and are available 

electronically at http://

www.regulations.gov. (FDA has verified 

the Web site addresses, but we are not 

responsible for any subsequent changes 

to the Web sites after this document 

publishes in the Federal Register.) 

1. CDRH’s Medical Devices Advisory 

Committee, available at http://www.fda.gov/

AdvisoryCommittees/

CommitteesMeetingMaterials/

MedicalDevices/

MedicalDevicesAdvisoryCommittee/

default.htm. 

2. ‘‘Guidance for Industry and FDA Staff: 

Guidance on Amended Procedures for 

Advisory Panel Meetings,’’ July 2000, 

available at http://www.fda.gov/downloads/

MedicalDevices/

DeviceRegulationandGuidance/

GuidanceDocuments/ucm073726.pdf. 

3. ‘‘Panel Review of Premarket Approval 

Applications #P91–2 (blue book memo),’’ 

May 1991, available at http://www.fda.gov/

MedicalDevices/

DeviceRegulationandGuidance/

GuidanceDocuments/ucm081363.htm. 

Dated: March 26, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–07438 Filed 3–31–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Advisory Council on Alzheimer’s 

Research, Care, and Services; Meeting 

AGENCY: Assistant Secretary for 

Planning and Evaluation, HHS. 

ACTION: Notice of meeting. 

SUMMARY: This notice announces the 

public meeting of the Advisory Council 

on Alzheimer’s Research, Care, and 

Services (Advisory Council). The 

Advisory Council on Alzheimer’s 

Research, Care, and Services provides 

advice on how to prevent or reduce the 

burden of Alzheimer’s disease and 

related dementias on people with the 

disease and their caregivers. During the 

April meeting, the Advisory Council 

will build on the goals of White House 

Conference on Aging (WHCOA) through 

a half-day session with dementiafocused panels on each WHCOA topic 

area: Healthy aging, long-term services 

and supports, retirement security, and 

elder justice. Following this session, the 

Advisory Council will also hold a brief 

discussion on the 2015 Update to the 

National Plan to Address Alzheimer’s, 

as well as a discussion of international 

events on dementia. 

DATES: The meeting will be held on 

April 28th, 2015 from 9:00 a.m. to 5:00 

p.m. EDT. 

ADDRESSES: The meeting will be held in 

Room 800 in the Hubert H. Humphrey 

Building, 200 Independence Avenue 

SW., Washington, DC 20201. 

Comments: Time is allocated in the 

afternoon on the agenda to hear public 

comments. The time for oral comments 

will be limited to two (2) minutes per 

individual. In lieu of oral comments, 

formal written comments may be 

submitted for the record to Rohini 

Khillan, OASPE, 200 Independence 

Avenue SW., Room 424E, Washington, 

DC 20201. Comments may also be sent 

to napa@hhs.gov. Those submitting 

written comments should identify 

themselves and any relevant 

organizational affiliations. 

FOR FURTHER INFORMATION CONTACT: 

Rohini Khillan (202) 690–5932, 

rohini.khillan@hhs.gov. Note: Seating 

may be limited. Those wishing to attend 

the meeting must send an email to 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 80, No. 62 / Wednesday, April 1, 2015 / Notices 17441 

napa@hhs.gov and put ‘‘April 28 

Meeting Attendance’’ in the Subject line 

by Friday, April 17, so that their names 

may be put on a list of expected 

attendees and forwarded to the security 

officers at the Department of Health and 

Human Services. Any interested 

member of the public who is a non-U.S. 

citizen should include this information 

at the time of registration to ensure that 

the appropriate security procedure to 

gain entry to the building is carried out. 

Although the meeting is open to the 

public, procedures governing security 

and the entrance to Federal buildings 

may change without notice. If you wish 

to make a public comment, you must 

note that within your email. 

SUPPLEMENTARY INFORMATION: Notice of 

these meetings is given under the 

Federal Advisory Committee Act (5 

U.S.C. App. 2, section 10(a)(1) and 

(a)(2)). Topics of the Meeting: The 

Advisory Council will hear 

presentations on the basics of long-term 

care, including presentations on 

programs, settings, and payers. The 

Council will use a portion of the 

meeting to review the work it has 

accomplished thus far towards the 2025 

goals, and then discuss the process for 

developing recommendations for the 

2015 update to the National Plan. The 

Council will also hear presentations 

from the three subcommittees (Research, 

Clinical Care, Long-Term Services and 

Supports, and Ethics). 

Procedure and Agenda: This meeting 

is open to the public. Please allow 30 

minutes to go through security and walk 

to the meeting room. The meeting will 

also be webcast at www.hhs.gov/live. 

Authority: 42 U.S.C. 11225; Section 2(e)(3) 

of the National Alzheimer’s Project Act. The 

panel is governed by provisions of Public 

Law 92–463, as amended (5 U.S.C. Appendix 

2), which sets forth standards for the 

formation and use of advisory committees. 

Dated: March 25, 2015. 

Richard G. Frank, 

Assistant Secretary for Planning and 

Evaluation. 

[FR Doc. 2015–07374 Filed 3–31–15; 8:45 am] 

BILLING CODE 4150–05–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Office of Dietary Supplements VDSP 

Commutability Study 2 

SUMMARY: NIH Office of Dietary 

Supplements (ODS) and the National 

Institute of Standards and Technology 

(NIST), in collaboration with the College 

of American Pathologists (CAP) and 

Vitamin D External Quality Assessment 

Scheme (DEQAS), announce that as part 

of the Vitamin D Standardization 

Program (VDSP), they are recruiting 

laboratories to participate in a study of 

the commutability of pooled serum 

samples used in assays to measure total 

25-hydroxyvitamin D [25(OH)D]. 

DATES: The expected start date for the 

study is June 2015. 

ADDRESSES: For more information about 

the study and to let us know if you are 

interested in participating, please 

contact us at: vdsp@mail.nih.gov. 

FOR FURTHER INFORMATION CONTACT: Drs. 

Johanna Camara, NIST, and Christopher 

Sempos, ODS, Director and Co-Director, 

respectively, for the VDSP 

Commutability Study 2. Email: VDSP@

mail.nih.gov. 

SUPPLEMENTARY INFORMATION: The 

objective of the study is to promote the 

standardized measurement of total 

25(OH)D by evaluating the 

commutability of NIST Standard 

Reference Materials® (SRM) used as 

‘‘trueness’’ controls and the materials 

used in the major Performance Testing/ 

External Quality (PT/EQA) programs 

administered by CAP and DEQAS. Who 

Can Participate: (1) All commercial 

manufacturers of 25(OH)D assays 

(requests from manufacturers with 

assays in development will be 

considered); (2) Clinical and research 

laboratories using a commercial assay 

platform; (3) Laboratories for national/

subnational nutrition surveys; and (4) 

Laboratories using in-house developed 

assays. 

For details about the study design and 

time lines, see the recently published 

paper in the February 2015 edition of 

Clinical Laboratory News, (https://

www.aacc.org/publications/cln/articles/

2015/february/vitamin-dcommutability-study). 

Dated: March 24, 2015. 

Lawrence A. Tabak, 

Deputy Director, National Institutes of Health. 

[FR Doc. 2015–07326 Filed 3–31–15; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Aging; 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 Institute on 

Aging Special Emphasis Panel; Fibroblast 

Growth Factor And Aging. 

Date: May 1, 2015. 

Time: 1:00 p.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute on Aging, 

Gateway Building, Suite 2C212, 7201 

Wisconsin Avenue, Bethesda, MD 20892, 

(Telephone Conference Call). 

Contact Person: Alicja L. Markowska, 

Ph.D., DSC., Scientific Review Branch, 

National Institute On Aging, 7201 Wisconsin 

Avenue, Suite 2c212, Bethesda, MD 20892, 

301–496–9666, markowsa@nia.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.866, Aging Research, 

National Institutes of Health, HHS) 

Dated: March 26, 2015. 

Melanie J. Gray, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2015–07338 Filed 3–31–15; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Aging; Notice of 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

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

hereby given of a meeting of the Board 

of Scientific Counselors, NIA. 

The meeting will be open to the 

public as indicated below, with 

attendance 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 Contact Person listed below 

in advance of the meeting. 

The meeting will be closed to the 

public as indicated below in accordance 

with the provisions set forth in section 

552b(c)(6), Title 5 U.S.C., as amended 

for the review, discussion, and 

evaluation of individual intramural 

programs and projects conducted by the 

NATIONAL INSTITUTE ON AGING, 

including consideration of personnel 

qualifications and performance, and the 

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