18850 Federal Register / Vol. 80, No. 67 / Wednesday, April 8, 2015 / Notices 

Leroy A. Richardson, 

Chief, Information Collection Review Office, 

Office of Scientific Integrity, Office of the 

Associate Director for Science, Office of the 

Director, Centers for Disease Control and 

Prevention. 

[FR Doc. 2015–08028 Filed 4–7–15; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–0986] 

Center for Devices and Radiological 

Health: Experiential Learning Program 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA), Center for 

Devices and Radiological Health (CDRH 

or Center) is announcing the 2015 

Experiential Learning Program (ELP). 

This training component is intended to 

provide CDRH staff with an opportunity 

to understand the policies, laboratory 

practices, and challenges faced in 

broader disciplines that impact the 

device development life cycle. The 

purpose of this document is to invite 

medical device industry, academia, and 

health care facilities to apply to 

participate in this formal training 

program for FDA’s medical device 

review staff, or to contact CDRH for 

more information regarding the ELP. 

DATES: Submit either an electronic or 

written request for participation in the 

ELP by May 8, 2015. The proposal 

should include a description of your 

facility relative to focus areas described 

in tables 1or 2). Please include the Area 

of Interest (see tables 1or 2) that the site 

visit will demonstrate to CDRH staff, a 

contact person, site visit location(s), 

length of site visit, proposed dates, and 

maximum number of CDRH staff that 

can be accommodated during a site 

visit. Proposals submitted without this 

minimum information will not be 

considered. In addition, please include 

an agenda outlining the proposed 

training for the site visit. A sample 

request and agenda are available on the 

ELP Web site at http://www.fda.gov/

downloads/ScienceResearch/

ScienceCareerOpportunities/

UCM392988.pdf and http://

www.fda.gov/scienceresearch/

sciencecareeropportunities/

ucm380676.htm. 

ADDRESSES: Submit either electronic 

requests to http://www.regulations.gov 

or written requests to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

Identify proposals with the docket 

number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Latonya Powell, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 5232, Silver Spring, 

MD 20993–0002, 301–796–6965, FAX: 

301–827–3079, Latonya.powell@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

CDRH is responsible for ensuring the 

safety and effectiveness of medical 

devices marketed in the United States. 

Furthermore, CDRH assures that 

patients and providers have timely and 

continued access to high-quality, safe, 

and effective medical devices. In 

support of this mission, the Center 

launched various training and 

development initiatives to enhance 

performance of its staff involved in 

regulatory review and in the premarket 

review process. One of these initiatives, 

the ELP Pilot, was launched in 2012 and 

fully implemented on April 2, 2013 (78 

FR 19711). CDRH is committed to 

advancing regulatory science; providing 

industry with predictable, consistent, 

transparent, and efficient regulatory 

pathways; and helping to ensure 

consumer confidence in medical 

devices marketed in the United States 

and throughout the world. The ELP is 

intended to provide CDRH staff with an 

opportunity to understand the policies, 

laboratory practices, and challenges 

faced in broader disciplines that impact 

the device development life cycle. This 

is a collaborative effort to enhance 

communication and facilitate the 

premarket review process. Furthermore, 

CDRH is committed to understanding 

current industry practices, innovative 

technologies, regulatory impacts, and 

regulatory needs. 

These formal training visits are not 

intended for FDA to inspect, assess, 

judge, or perform a regulatory function 

(e.g., compliance inspection), but rather, 

they are an opportunity to provide 

CDRH review staff a better 

understanding of the products they 

review. Through this notice, CDRH is 

formally requesting participation from 

companies, academia, and clinical 

facilities, including those that have 

previously participated in the ELP or 

other FDA site visit programs. 

II. ELP 

A. ELP Training Component 

In this training program, groups of 

CDRH staff will observe operations at 

research, manufacturing, academia, and 

health care facilities. The focus areas 

and specific areas of interest for visits 

may include the following: 

TABLE 1—AREAS OF INTEREST—MEDICAL DEVICES/TECHNOLOGY

Focus area Specific areas of interest 

Failure analysis of orthopedic devices.Methods for retrieval and preservation of failed implants for analysis; understanding how retrieved implants 

may be analyzed; methods for identifying failure modes; understanding how analysis of failed implants 

influences device design modifications. 

Radiologic analysis of orthopedic 

devices.

Methods of radiologic analysis and associated data analyses; radiologic imaging core laboratories. 

Automated external defibrillators 

(AEDs).

Manufacturing process; incoming component inspection; design verification testing; human factors testing; 

returned product testing (as available). 

Diagnostic imaging catheters for 

cardiovascular diseases.

Manufacturing process; design verification testing; returned product testing (as available); ultrasound, optical coherence tomography (OCT), and near infrared spectroscopy (NIS) catheters. 

Endovascular grafts for treatment of 

aortic aneurysms.

Physician-sponsored clinical studies; observation of endovascular grafting surgical procedure; surgical 

planning process; factors that influence device modifications (e.g., patient anatomy, patient pathology). 

Animal models for evaluation of hemostatic devices.Models of traumatic injury and severe hemorrhage; limitations of the model; understanding the relevance 

of the data generated from these models in evaluating hemostatic devices. 

Hyaluronic acid in dermal tissue 

fillers.

Manufacturing process; source materials; performance testing (e.g., material characterization, biocompatibility, residence time). 

Minimally invasive glaucoma surgery (MIGS) devices.Observation of a MIGS procedure; surgical planning; surgical challenges. 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 67 / Wednesday, April 8, 2015 / Notices 18851 

TABLE 1—AREAS OF INTEREST—MEDICAL DEVICES/TECHNOLOGY—Continued 

Focus area Specific areas of interest 

Neurointerventional devices ............ Stents, flow-diverters, mesh balls, coils, and other related devices; observation of surgical procedures; understanding of clinical decision making for relevant patient populations; manufacturing; performance testing. 

Implantable functional electrical 

stimulation devices.

Observation of implantation procedure; surgical challenges. 

Male condoms ................................. Manufacturing process; lot release testing (e.g., airburst, water leak, dimensional analysis). 

Solid organ preservation devices ... Observation of organ preservation procedures; pulsatile perfusion (for either cold storage or 

normothermia). 

Infusion pumps ................................ Manufacturing process; device design considerations; patch pumps; insulin pumps; implantable infusion 

pumps; implantable ports. 

Bone grafting materials for dental 

applications.

Manufacturing process; sourcing process; viral inactivation testing; animal testing. 

TABLE 2—AREAS OF INTEREST—IN VITRO DIAGNOSTIC AND RADIOLOGICAL DEVICES/TECHNOLOGY

Focus area Specific areas of interest 

Manufacturing of glucose test strips 

and meters.

Observation of the manufacturing and in-process and finished device testing of glucose monitoring devices. 

Manufacturing of continuous glucose monitoring systems and insulin pumps.Observation of the manufacturing and in-process and finished device testing of glucose monitors and insulin pumps. 

Manufacturing of chemistry devices Observation of the manufacturing and in-process and finished device testing of point of care chemistry 

cassettes/cartridges/strips for smaller chemistry analyzers used in clinical and point of care settings. 

Manufacturing of chemistry reagent, 

controls and calibrators.

Observation of the manufacturing and in-process and finished device testing of chemistry reagents, calibrators, and controls for common chemistry analytes used in a clinical laboratory setting. 

Manufacturing of urine test strips 

and readers.

Manufacturing and observation of in process or finished device testing for urine test strips and meters in 

clinical laboratory and point of care testing settings. 

Manufacturing and development of 

IHC (immunohistochemistry) devices.

Observation of manufacturing, in-process testing, and/or finished device testing of IHC devices (used in the 

diagnostic evaluation of cancer, classification of tumors, or companion diagnostic testing). 

Manufacturing and development of 

ISH (in situ hybridization) devices.

Observation of the manufacturing, in-process testing, or finished device testing of colorimetric in situ hybridization (CISH) and/or fluorescent in situ hybridization (FISH) assays used in identifying specific nucleic acid sequences within tissue sections (for diagnostic and/or treatment decisions). 

Manufacturing and development of 

NGS (next gen sequencing) platforms and devices.

Observation of NGS sequencing platforms, bioinformatic analysis of the resulting sequence information, 

and types of interpretative software for potential clinical purposes. 

Manufacturing, development and 

observation of CTC (circulating 

tumor cells) devices.

Observation of the manufacturing, in-process testing, or finished device testing of CTC devices that assess 

the prognosis of patients with metastatic breast, colorectal, or prostate cancer (manufacturing site or research site or clinical setting). 

Manufacturing, development and/or 

observation of clinical mass 

spectrometers and high performance liquid chromatography 

(HPLC) devices.

Observe the manufacturing, development and/or demonstration of clinical mass spectrometers and HPLC 

as part of laboratory workflow including sample preparation, equipment usage, and data analysis. 

Manufacturing, development and 

research of flow cytometry devices and components.

Manufacturing, research, and development of in-process testing, or finished device testing of cytometry 

analyzers and accompanying components. 

Manufacturing of immunoassays for 

autoimmune diseases.

Manufacturing and development of in-process testing, or finished device testing, for diagnostic evaluation 

and research. 

Manufacturing and development of 

coagulation—point of care devices.

Manufacturing and development of in-process or finished device testing for point of care devices such as 

Prothrombin Time and International Normalized Ratio (PT/INR) meters. 

Manufacturing and product development of global hemostasis 

testing devices.

Manufacturing of global hemostasis testing for anti-coagulants and anti-platelet drugs for new molecular 

targets to assess the level of drug-induced inhibition for qualitative and quantitative evaluation. 

Manufacturing and product development of direct anticoagulants 

assays/controls/calibrators.

Manufacturing and development of assays, controls, and calibrators for the detection of direct 

anticoagulants. 

Observation of testing of sequencing technologies in large sequencing centers.Visit a sequencing center where various sequencing methods are used for different applications other than 

in vitro diagnostic devices (IVD) manufacturing. 

Manufacturing, and product evaluation of IVDs using next generation sequencing (NGS) technology.Visit a manufacturer of IVD designed for sequencing of microorganisms for identification purposes. 

Clinical applications-NGS in practice.Visit a clinical laboratory that uses NGS as a diagnostic/screening tool. 

Antimicrobial susceptibility testing 

(AST).

Visit to a manufacturer of antimicrobial susceptibility test platforms intended for use in clinical laboratory 

settings. 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
18852 Federal Register / Vol. 80, No. 67 / Wednesday, April 8, 2015 / Notices 

TABLE 2—AREAS OF INTEREST—IN VITRO DIAGNOSTIC AND RADIOLOGICAL DEVICES/TECHNOLOGY—Continued 

Focus area Specific areas of interest 

Antimicrobial susceptibility testing 

(AST).

Visit to a clinical laboratory that employs various AST methodologies for identification of antibiotic resistance. 

B. Site Selection 

CDRH will be responsible for CDRH 

staff travel expenses associated with the 

site visits. CDRH will not provide funds 

to support the training provided by the 

site to this ELP. Selection of potential 

facilities will be based on CDRH’s 

priorities for staff training and resources 

available to fund this program. In 

addition to logistical and other resource 

factors, all sites must have a successful 

compliance record with FDA or another 

Agency with which FDA has a 

memorandum of understanding. If a site 

visit involves a visit to a separate 

physical location of another firm under 

contract with the site, that firm must 

agree to participate in the ELP and must 

also have a satisfactory compliance 

history. 

III. Request for Participation 

Submit proposals for participation 

with the docket number found in the 

brackets in the heading of this 

document. Received requests may be 

seen in the Division of Dockets 

Management (see ADDRESSES) between 9 

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

Friday. 

Dated: April 2, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–08017 Filed 4–7–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

DEPARTMENT OF AGRICULTURE 

Solicitation of Written Comments on 

the Scientific Report of the 2015 

Dietary Guidelines Advisory 

Committee; Extension of Comment 

Period 

AGENCY: Office of the Assistant 

Secretary for Health, Office of the 

Secretary, Department of Health and 

Human Services; and Food, Nutrition 

and Consumer Services and Research, 

Education, and Economics. U.S. 

Department of Agriculture. 

ACTION: Notice. 

SUMMARY: A notice was published in the 

Federal Register on Monday, February 

23, 2015, Vol. 80, No. 35, pages 9465– 

9466 to announce the availability of the 

Scientific Report of the 2015 Dietary 

Guidelines Advisory Committee 

(Advisory Report) and to solicit written 

comments on the Advisory Report 

(among other things). In the notice dated 

February 23, 2015, it was announced 

that the due date for providing 

comments was April 8, 2015. This 

notice is to announce the extension of 

the solicitation period to allow for 

additional time for written comments to 

be submitted for consideration. 

DATES: The comment period is extended 

and thus will end at 11:59 p.m., E.D.T. 

on May 8, 2015. 

ADDRESSES: The Advisory Report is 

available on the Internet at 

www.DietaryGuidelines.gov. Written 

public comments on the Advisory 

Report can be submitted and/or viewed 

at www.DietaryGuidelines.gov using the 

‘‘Submit Comments’’ and ‘‘Read 

Comments’’ links, respectively. 

FOR FURTHER INFORMATION CONTACT: 

Designated Federal Officer (DFO), 2015 

DGAC, Richard D. Olson, M.D., M.P.H.; 

Office of Disease Prevention and Health 

Promotion, OASH/HHS; 1101 Wootton 

Parkway, Suite LL100 Tower Building; 

Rockville, MD 20852: Telephone: (240) 

453–8280; Fax: (240) 453–8281; 

Alternate DFO, 2015 DGAC, Kellie 

(O’Connell) Casavale, Ph.D., R.D., 

Nutrition Advisor; Office of Disease 

Prevention and Health Promotion, 

OASH/HHS; 1101 Wootton Parkway, 

Suite LL100 Tower Building; Rockville, 

MD 20852: Telephone: (240) 453–8280; 

Fax: (240) 453–8281; Lead USDA CoExecutive Secretary, Colette I. Rihane, 

M.S., R.D., Director, Office of Nutrition 

Guidance and Analysis, Center for 

Nutrition Policy and Promotion, USDA; 

3101 Park Center Drive, Room 1034; 

Alexandria, VA 22302; Telephone: (703) 

305–7600; Fax: (703) 305–3300; and/or 

USDA Co-Executive Secretary, Shanthy 

A. Bowman, Ph.D., Nutritionist, Food 

Surveys Research Group, Beltsville 

Human Nutrition Research Center, 

Agricultural Research Service, USDA; 

10300 Baltimore Avenue, BARC-West 

Bldg. 005, Room 125; Beltsville, MD 

20705–2350; Telephone: (301) 504– 

0619. 

Dated: March 24, 2015. 

Don Wright, 

Deputy Assistant Secretary for Health, Office 

of Disease Prevention and Health Promotion, 

Office of the Assistant Secretary for Health, 

U.S. Department of Health and Human 

Services. 

Dated: March 24, 2015. 

Angela Tagtow, 

Executive Director, Center for Nutrition Policy 

and Promotion, U.S. Department of 

Agriculture. 

Dated: March 23, 2015. 

Steven R. Shafer, 

Associate Administrator, Agricultural 

Research Service, U.S. Department of 

Agriculture. 

[FR Doc. 2015–08049 Filed 4–7–15; 8:45 am] 

BILLING CODE 4150–32–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Office of the Director, Office of Science 

Policy, Office of Biotechnology 

Activities; Notice of Meeting 

Pursuant to section 10(a) of the 

Federal Advisory Committee Act, as 

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

hereby given of the meeting of the 

National Science Advisory Board for 

Biosecurity (NSABB). 

Name of Committee: National Science 

Advisory Board for Biosecurity. 

Date: May 5, 2015. 

Time: 8:30 a.m.—3:30 p.m. Eastern. 

Agenda: Presentations and discussions 

regarding: (1) NSABB’s proposed framework 

for guiding risk and benefit assessments of 

gain-of-function (GOF) studies involving 

pathogens with pandemic potential; (2) 

overview of conducting the risk and benefit 

assessments; (3) planning for future NSABB 

deliberations on the GOF issue; and (4) other 

business of the Board. 

Place: National Institutes of Health, 9000 

Rockville Pike, Building 31, 6th Floor 

Conference 10, Bethesda, Maryland 20892. 

Contact Person: Carolyn Mosby, NSABB 

Program Assistant, NIH Office of 

Biotechnology Activities, 6705 Rockledge 

Drive, Suite 750, Bethesda, Maryland 20892, 

(301) 435–5504, carolyn.mosby@nih.gov. 

Under authority 42 U.S.C. 217a, Section 

222 of the Public Health Service Act, as 

amended, the Department of Health and 

Human Services established the National 

Science Advisory Board for Biosecurity 

(NSABB) to provide advice regarding federal 

oversight of dual use research, defined as 


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