Federal Register / Vol. 80, No. 62 / Wednesday, April 1, 2015 / Notices 17439 

ADDRESSES: Interested parties may 

participate in the dialogue through the 

online platform by reviewing the 

information and participation dates 

posted at www.cao.gov. 

FOR FURTHER INFORMATION CONTACT: 

Christopher Zeleznik at dataactpmo@

hhs.gov or 202–205–3514 or Emily 

Gartland at IAEOutreach@gsa.gov or 

703–605–2532. 

SUPPLEMENTARY INFORMATION: 

This notice announces a dialogue to 

explore opportunities to streamline 

processes and reduce or eliminate 

burden in federal procurement and 

grants processes. This dialogue furthers 

the goals of the President’s Management 

Agenda, which lays the foundation for 

creating a 21st century government that 

delivers better results to the American 

people, and addresses requirements in 

the Digital Accountability and 

Transparency Act of 2014 (Public Law 

113–101) to gain a better understanding 

of the costs of compliance with Federal 

contracting and grants awards as well as 

recommendations to standardize data, 

eliminate unnecessary duplication, and 

reduce compliance costs. 

During last year’s Open Dialogue on 

Federal Procurement, published in the 

Federal Register at 79 FR 22682, on 

April 23, 2014, many commenters 

pointed to the potential reduction of 

redundant reporting and related 

processes as one way to improve the 

efficiency and effectiveness of the 

government’s acquisition practices. This 

feedback is helping to support ongoing 

efforts to modernize the IT 

infrastructure supporting Federal 

procurement data collection and 

display, which will include 

development of a single Web site for 

Federal contractors to use for federal 

contract reporting requirements. 

Management of federal contract and 

grant business arrangements requires 

multiple layers of reporting across 

multiple agencies. In some cases, lack of 

standardization results in slight (or 

significant) variations in reports that 

create additional administrative and 

burdensome requirements for awardees 

that could be readily rectified. This 

dialogue is intended to continue the 

conversation begun last year in the 

context of federal procurement and 

expand it to cover federal grants by 

identifying opportunities for reducing 

burden, discussing ideas for 

standardizing processes and forms, and 

identifying recommended actions to 

reduce costs and eliminate duplication 

for awardees. The open dialogue focuses 

on three topics (campaigns). Each 

campaign focuses on a unique aspect of 

the Federal contracting and grants 

process for which we welcome your 

insight, ideas, and feedback. 

• Campaign 1—Reporting compliance 

requirements shared by prime and subawardees of Federal procurements and 

grants. 

• Campaign 2—Procurement 

practices, processes, and reporting. 

• Campaign 3—Grants practices and 

processes. 

Note—We are looking for ideas to 

reduce your burden through data 

standards and changes to reporting 

procedures. We are interested in hearing 

about proposed changes that can be 

accomplished through executive 

(regulatory, administrative, or 

management) action, as well as 

potential legislative proposals where 

requirements are based in statute. 

To facilitate a national dialogue, an 

online platform will be launched in May 

2015 so that interested parties may 

submit ideas, comment on others, 

respond to questions posed by 

moderators, and vote to indicate which 

ideas they think are most promising and 

impactful. Information on the platform, 

and the dates for participating in the 

dialogue, will be posted at www.cao.gov. 

A separate notice will beposted to 

address additional dialogue topics on 

federal procurement for conversation 

later in the spring and summer. 

Dated: March 27, 2015. 

William Clark, 

Director, Office of Government-wide 

Acquisition Policy, Office of Acquisition 

Policy, Office of Government-wide Policy. 

[FR Doc. 2015–07441 Filed 3–31–15; 8:45 am] 

BILLING CODE 6820–EP–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–D–0838] 

Procedures for Meetings of the Medical 

Devices Advisory Committee; Draft 

Guidance for Industry and Food and 

Drug Administration Staff; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the draft guidance 

entitled ‘‘Procedures for Meetings of the 

Medical Devices Advisory Committee.’’ 

The Center for Devices and Radiological 

Health (CDRH) is issuing this guidance 

to provide additional information 

regarding the processes for meetings of 

the Medical Devices Advisory 

Committee panels other than the 

Dispute Resolution Panel (DRP). This 

guidance describes the general 

circumstances in which CDRH consults 

with a panel, the process for exchange 

of information between CDRH, the 

members of the panel, industry, and the 

public, and the conduct of panel 

meetings. This guidance supplements 

existing FDA Agency-wide guidance on 

the conduct of Advisory Committee 

meetings. This draft guidance is not 

final nor is it in effect at this time. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment of this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by June 1, 2015. 

ADDRESSES: An electronic copy of the 

guidance document is available for 

download from the Internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. Submit written requests for a 

single hard copy of the draft guidance 

document entitled ‘‘Procedures for 

Meetings of the Medical Devices 

Advisory Committee’’ to the Office of 

the Center Director, Guidance and 

Policy Development, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5431, Silver Spring, 

MD 20993–0002. Send one selfaddressed adhesive label to assist that 

office in processing your request. 

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. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

James Swink, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 1609, Silver Spring, 

MD 20993–0002, 301–796–6313. 

SUPPLEMENTARY INFORMATION: 

I. Background 

CDRH is issuing this draft guidance to 

provide additional information 

regarding the processes for meetings of 

the Medical Devices Advisory 

Committee panels other than the DRP. 

The term ‘‘panel,’’ as used in this 

guidance, refers to the panels 

established under the Medical Devices 

Advisory Committee charter excluding 

the DRP. This guidance describes the 

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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 

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