Federal Register / Vol. 80, No. 36 / Tuesday, February 24, 2015 / Notices 9733 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–0001] 

Anesthetic and Analgesic Drug 

Products Advisory Committee; Notice 

of Meeting; Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; correction. 

SUMMARY: The Food and Drug 

Administration is correcting a notice 

entitled ‘‘Anesthetic and Analgesic Drug 

Products Advisory Committee; Notice of 

Meeting’’ that appeared in the Federal 

Register of February 6, 2015 (80 FR 

6731). The document announced a 

forthcoming meeting of a public 

advisory committee of the Food and 

Drug Administration (FDA). The 

document was published with the 

incorrect docket number. This 

document corrects that error. 

FOR FURTHER INFORMATION CONTACT: Lisa 

Granger, Office of Policy, Planning, 

Legislation, and Analysis, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 32, Rm. 3330, 

Silver Spring, MD 20993, 301–796– 

9115. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of February 6, 2015, in 

FR Doc. 2015–02408, on page 6731, the 

following correction is made: 

On page 6731, in the first column, in 

the Docket No. heading, ‘‘[Docket No. 

FDA–2011–N–0824]’’ is corrected to 

read ‘‘[Docket No. FDA–2015–N–0001]’’. 

Dated: February 17, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–03688 Filed 2–23–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–0001] 

Neurological Devices Panel of the 

Medical Devices Advisory Committee; 

Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Neurological 

Devices Panel of the Medical Devices 

Advisory Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the Agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on April 17, 2015, from 8 a.m. to 

4 p.m. 

Location: FDA White Oak Campus, 

10903 New Hampshire Ave., Building 

31 Conference Center, the Great Room 

(rm. 1503), Silver Spring, MD 20993– 

0002. Answers to commonly asked 

questions including information 

regarding special accommodations due 

to a disability, visitor parking, and 

transportation may be accessed at: 

http://www.fda.gov/

AdvisoryCommittees/

AboutAdvisoryCommittees/

ucm408555.htm. 

Contact Person: Jamie Waterhouse, 

Center for Devices and Radiological 

Health, Food and Drug Administration, 

10903 New Hampshire Ave., Silver 

Spring, MD 20993, Jamie.Waterhouse@

fda.hhs.gov, 301–796–3063, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area). A notice in the 

Federal Register about last minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check the 

Agency’s Web site at http://

www.fda.gov/AdvisoryCommittees/

default.htm and scroll down to the 

appropriate advisory committee meeting 

link, or call the advisory committee 

information line to learn about possible 

modifications before coming to the 

meeting. 

Agenda: On April 17, 2015, the 

committee will discuss the current 

knowledge regarding the conduct of 

clinical studies and evaluation of 

clinical study data for flow diverter 

technology. FDA is convening this 

committee to seek expert opinion on 

scientific and clinical considerations 

relating to the study design and existing 

clinical studies, for flow diverter 

technology indicated for the 

neurovasculature. 

Flow diverters are an endoluminal 

treatment option for intracranial 

aneurysms. They are similar to 

traditional stents in their tubular metal 

structure but with a significantly higher 

mesh density. The working principle is 

that the high-mesh density reduces flow 

rate into the aneurysm which promotes 

blood stasis and occlusion of the 

aneurysm. Flow diverters are 

advantageous for the treatment of large/ 

giant wide-neck aneurysms and offer an 

alternative to other interventional 

techniques or surgery. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

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

AdvisoryCommittees/Calendar/

default.htm. Scroll down to the 

appropriate advisory committee meeting 

link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before April 3, 2015. Oral 

presentations from the public will be 

scheduled between approximately 10:30 

a.m. and 11:30 a.m. Those individuals 

interested in making formal oral 

presentations should notify the contact 

person and submit a brief statement of 

the general nature of the evidence or 

arguments they wish to present, the 

names and addresses of proposed 

participants, and an indication of the 

approximate time requested to make 

their presentation on or before March 

24, 2015. Time allotted for each 

presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by March 27, 2015. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

Agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact AnnMarie 

Williams at Annmarie.Williams@

fda.hhs.gov, or 301–796–5966 at least 7 

days in advance of the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/

AdvisoryCommittees/

AboutAdvisoryCommittees/

ucm111462.htm for procedures on 


tkelley on DSK3SPTVN1PROD with NOTICES
9734 Federal Register / Vol. 80, No. 36 / Tuesday, February 24, 2015 / Notices 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: February 17, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–03687 Filed 2–23–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–0012] 

Partnership To Develop the Branded 

Food Products Database for Public 

Health (R01) 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of grant funds for the 

support of the Agricultural Technology 

Innovation Partnership’s (ATIP) 

Branded Food Products Database for 

Public Health. ATIP, in conjunction 

with the U.S. Department of Agriculture 

(USDA) Agricultural Research Service 

(ARS) and the International Life Science 

Institute North America (ILSI North 

America), has established a publicprivate partnership to enhance the 

public’s health. The Office of Foods and 

Veterinary Medicine (OFVM) has grant 

funds available to help support ATIP 

consolidate food composition data from 

manufacturers. OFVM’s goal is to 

monitor the sodium content of branded 

foods and to make nutrient composition 

data available to the public. 

DATES: Important dates are as follows: 

1. The application due date is April 

2, 2015. 

2. The anticipated start date is May 

2015. 

3. The opening date is February 13, 

2015. 

4. The expiration date is April 3, 

2015. 

ADDRESSES: For more information, see 

section III of the SUPPLEMENTARY

INFORMATION section of this notice. 

FOR FURTHER INFORMATION CONTACT: 

Claudine Kavanaugh, Office of Foods 

and Veterinary Medicine, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993, 301–796–4647; or Vieda 

Hubbard, Division of Acquisition 

Support and Grants, Food and Drug 

Administration, 5630 Fishers Lane 

(HFA–500), Rockville, MD 20857, 240– 

402–7588. 

For more information on this funding 

opportunity announcement (FOA) and 

to obtain detailed requirements, please 

refer to the full FOA. 

SUPPLEMENTARY INFORMATION: 

I. Funding Opportunity Description 

RFA–FD–15–005 

93.103 

A. Background 

OFVM is interested in monitoring the 

sodium content of branded foods in the 

U.S. marketplace. Knowing the nutrient 

profile of branded foods is critical to 

FDA’s work and to the public’s health. 

Public health experts have linked 

excessive sodium consumption to 

hypertension, cardiovascular disease, 

and other chronic diseases. A database 

that reflects the sodium content of foods 

will help OFVM research strategies 

regarding sodium reduction and help 

the public maintain healthy diets. 

OFVM has funds available for ATIP to 

compile compositional data for branded 

foods for the public’s benefit. ATIP, 

through ILSI North America and USDA, 

has experience engaging the private 

sector and expertise compiling brand 

data. With OFVM’s fiscal contribution, 

ATIP will be able to build upon USDA’s 

National Nutrient Database—widely 

recognized as the gold standard for food 

compositional data—in a timely fashion. 

ATIP’s database will reflect the breadth 

and depth of the nation’s food supply 

and will facilitate nutrition analysis and 

research that otherwise may not be 

possible. 

The research community, healthcare 

professionals, the food industry, and 

policymakers will use ATIP’s database. 

For example, drafters of the National 

Health and Nutrition Examination 

Survey will be able to more accurately 

characterize food selection and sodium 

consumption for Americans. Medical 

researchers will be able to better link 

sodium intake to measures of chronic 

diseases. Food manufacturers will be 

able to compare information to improve 

product formulations. Policy-making 

bodies will be able to develop better 

guidelines that will promote public 

health. Ultimately, having more robust 

sodium data available will allow FDA to 

develop targeted sodium reduction 

strategies and the public to better 

monitor sodium intake. 

B. Research Objectives 

ATIP will compile compositional data 

for branded foods for the public’s 

benefit. The database will include food 

group information on branded foods and 

branded restaurant food products. ATIP 

will manage a large volume of datestamped branded product information 

to link food intake and nutrient 

composition to dietary patterns 

recommendations. ATIP will collect and 

publish comprehensive food 

compositional data, including sodium 

content, in a timely fashion. 

C. Eligibility Information 

This grant is available solely for ATIP. 

Through ILSI North America and USDA, 

respectively, ATIP has existing 

relationships with industry and years of 

food compositional data upon which 

ATIP can build. ATIP has already 

demonstrated that its database can 

effectively manage a large volume of 

date-stamped branded product 

information. Compiling additional 

compositional data for branded foods 

will allow FDA to link sodium intake 

and composition data to dietary patterns 

recommendations more efficiently. 

II. Award Information/Funds Available 

A. Award Amount 

OFVM has $35,000 available for a 

single award to a single grantee—ATIP. 

B. Length of Support 

This grant is available for 1 year from 

the start date. 

III. Electronic Application, 

Registration, and Submission 

Only electronic applications will be 

accepted. To submit an electronic 

application in response to this FOA, 

applicant should first review the full 

announcement. (FDA has verified the 

Web site addresses throughout this 

document, but FDA is not responsible 

for any subsequent changes to the Web 

sites after this document publishes in 

the Federal Register.) For all 

electronically submitted applications, 

the following steps are required. 

• Step 1: Obtain a Dun and Bradstreet 

(DUNS) Number 

• Step 2: Register With System for 

Award Management (SAM) 

• Step 3: Obtain Username & Password 

• Step 4: Authorized Organization 

Representative (AOR) Authorization 

• Step 5: Track AOR Status 

• Step 6: Register With Electronic 

Research Administration (eRA) 

Commons 

Steps 1 through 5, in detail, can be 

found at http://www07.grants.gov/

applicants/organization_

registration.jsp. Step 6, in detail, can be 

found at https://commons.era.nih.gov/

commons/registration/

registrationInstructions.jsp. After you 

have followed these steps, submit 


tkelley on DSK3SPTVN1PROD with NOTICES