36608 Federal Register / Vol. 83, No. 146 / Monday, July 30, 2018 / Notices 

TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB 

Title of collection OMB control 

No. 

Date 

approval 

expires 

Blood Establishment Registration and Product Listing for Manufacturers of Human Blood and Blood Products 

and Licensed Devices; Form FDA 2830 .............................................................................................................. 0910–0052 6/30/2021 

Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donation Testing, Donor Notification, and ‘‘Lookback’’ ............................................................... 0910–0116 6/30/2021 

Current Good Manufacturing Practices for Finished Pharmaceuticals and Medical Gases ................................... 0910–0139 6/30/2021 

Prescription Drug Marketing .................................................................................................................................... 0910–0435 6/30/2021 

Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices ........................................................ 0910–0577 6/30/2021 

Guidance FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, 

Drug, and Cosmetic Act ....................................................................................................................................... 0910–0705 6/30/2021 

Utilization of Adequate Provision Among Low to Non-Internet Users .................................................................... 0910–0853 6/30/2021 

Record Retention Requirements for the Soy Protein/Coronary Heart Disease Health Claim ................................ 0910–0428 7/31/2021 

Dated: July 24, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–16156 Filed 7–27–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–2605] 

Center for Devices and Radiological 

Health: Experiential Learning Program 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration’s (FDA) Center for 

Devices and Radiological Health (CDRH 

or Center) is announcing the 2019 

Experiential Learning Program (ELP). 

This training is intended to provide 

CDRH and other FDA staff with an 

opportunity to understand laboratory 

practices, quality system management, 

patient perspective/input, and 

challenges that impact the medical 

device development life cycle. The 

purpose of this document is to invite 

medical device industry, academia, and 

health care facilities, and others to 

participate in this formal training 

program for CDRH and other FDA staff, 

or to contact CDRH for more 

information regarding the ELP. 

DATES: Submit electronic proposals for 

participation in the ELP at ELP@

fda.hhs.gov within the dates provided at 

the ELP website at https://www.fda.gov/ 

scienceresearch/sciencecareer

opportunities/ucm380676.htm. 

ADDRESSES: You may submit comments 

as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’ or 

submit electronic proposals to ELP@

fda.hhs.gov). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All comments received 

must include the Docket No. FDA– 

2018–N–2605 for ‘‘Center for Devices 

and Radiological Health: Experiential 

Learning Program.’’ Received comments 

will be placed in the docket and are 

publicly viewable at https://

www.regulations.gov or at the Dockets 

Management Staff between 9 a.m. and 4 

p.m., Monday through Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

requests only as a written/paper 

submission, or submit electronically to 

ELP@fda.hhs.gov. You should submit 

two copies total. One copy will include 

the information you claim to be 

confidential with a heading or cover 

note that states ‘‘THIS DOCUMENT 

CONTAINS CONFIDENTIAL 

INFORMATION.’’ The Agency will 

review this copy, including the claimed 

confidential information, in its 

consideration of requests. The second 

copy, which will have the claimed 

confidential information redacted/ 

blacked out, will be available for public 

viewing and posted on https://

www.regulations.gov. Submit both 

copies to the Dockets Management Staff. 

If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your requests and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of requests to public dockets, see 80 FR 

56469, September 18, 2015, or access 

the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 


daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 146 / Monday, July 30, 2018 / Notices 36609 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Christian Hussong, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 3283, Silver Spring, 

MD 20993–0002, 240–402–2246, or ELP 

Management, ELP@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

CDRH is responsible for ensuring the 

safety and effectiveness of medical 

devices marketed in the United States. 

Additionally, CDRH assures patients 

and providers have timely and 

continued access to high-quality, safe 

and effective medical devices. 

Continuing our 2016 and 2017 priorities 

of Partnering with Patients and 

Promoting a Culture of Quality and 

Organizational Excellence, adding our 

2018–2020 Strategic Priorities of 

Simplicity, Collaborative Communities 

and Employee Engagement, 

Opportunity, and Success, overlaid by 

our constant strive for patient safety and 

innovation highlights our need to 

understand the perspective of our 

stakeholders. The Center encourages 

applicants to consider including 

opportunities to discuss innovation, 

patient perspective, patient safety, 

incorporating quality system design and 

management, simplification principles, 

and utilization of collaborative 

communities in their proposal(s) as they 

contribute to the success of the device 

development life cycle. 

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 and other 

FDA staff with an opportunity to 

understand the laboratory and 

manufacturing practices, quality system 

management, patient perspective/input, 

simplification principles, and other 

challenges and how they impact the 

medical device development life cycle. 

ELP is a collaborative effort to enhance 

communication with our stakeholders to 

facilitate medical device reviews. The 

Center is committed to understanding 

current industry practices, innovative 

technologies, regulatory impacts and 

needs, and how patient perspective/ 

input, safety and quality systems 

management advance the development 

and evaluation of medical devices, and 

monitoring the performance of marketed 

devices. 

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 and other FDA staff a better 

understanding of the products they 

review, and how they are developed. 

Additionally, it is to understand 

challenges related to quality systems 

development and management and 

simplification in processes, patient 

preferences and safety, in the product 

life cycle, and how medical devices fit 

into the larger health care system. CDRH 

is formally requesting participation from 

industry, academia, and clinical 

facilities, medical device incubators and 

accelerators, health technology 

assessment groups, and those that have 

previously participated in the ELP or 

other FDA site visit programs. 

Additional information regarding the 

CDRH ELP, including current areas of 

interest, submission dates, a sample site 

visit request, and an example of a site 

visit agenda, is available on CDRH’s 

website at: https://www.fda.gov/ 

scienceresearch/ 

sciencecareeropportunities/ 

ucm380676.htm. 

II. CDRH ELP 

A. Areas of Interest 

In the ELP training program, groups of 

CDRH and other FDA staff will observe 

operations in the areas of research, 

device development, Digital Health, 

incorporating patient information and 

reimbursement, manufacturing, quality 

management principles, and health care 

facilities. The areas of interest for visits 

include various topics identified by 

managers at CDRH and other areas 

within FDA. These areas of interest are 

listed on the ELP website and are 

intended to be updated quarterly. 

To submit a proposal addressing one 

of the Center’s areas of interest, visit the 

link for the table of areas of interest at: 

https://www.fda.gov/ScienceResearch/ 

ScienceCareerOpportunities/ 

UCM380676.htm. 

Once you have determined an area of 

interest to address in your ELP proposal, 

follow the instructions in section III to 

complete the site visit request template 

and agenda provided at: https://

www.fda.gov/downloads/ 

ScienceResearch/ScienceCareer

Opportunities/UCM392988.pdf and at: 

https://www.fda.gov/downloads/ 

ScienceResearch/ScienceCareer

Opportunities/UCM487190.pdf. 

Submit all proposals at ELP@

fda.hhs.gov within the dates provided at 

the ELP website at: https://www.fda.gov/ 

scienceresearch/sciencecareer

opportunities/ucm380676.htm. 

B. Site Selection 

CDRH and FDA will be responsible 

for its own staff travel expenses 

associated with the site visits. CDRH 

and FDA will not provide funds to 

support the training provided by the site 

to the ELP. Selection of potential 

facilities will be based on CDRH and 

FDA’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 applicable). 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, and must be listed in the 

proposal along with a Facility 

Establishment Identifier number, if 

applicable. 

III. Request To Participate 

Information regarding the CDRH ELP, 

including a sample request and an 

example of a site visit agenda, and 

submission dates is available on CDRH’s 

website at: https://www.fda.gov/ 

scienceresearch/sciencecareer

opportunities/ucm380676.htm. 

Proposals to participate should be 

submitted at ELP@fda.hhs.gov, within 

the dates provided at the ELP website at: 

https://www.fda.gov/scienceresearch/ 

sciencecareeropportunities/ 

ucm380676.htm. 

Dated: July 24, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–16177 Filed 7–27–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Announcement of Meeting of the 

Secretary’s Advisory Committee on 

National Health Promotion and Disease 

Prevention Objectives for 2030 

AGENCY: Office of the Secretary, Office 

of the Assistant Secretary for Health, 

Office of Disease Prevention and Health 

Promotion, Department of Health and 

Human Services. 

ACTION: Notice. 

SUMMARY: The U.S. Department of 

Health and Human Services (HHS) 

announces the next meeting of the 


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