4632 Federal Register / Vol. 81, No. 17 / Wednesday, January 27, 2016 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–D–4803] 

Public Notification of Emerging 

Postmarket Medical Device Signals 

(’Emerging Signals’); Draft Guidance 

for Industry and Food and Drug 

Administration Staff; Extension of 

Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; extension of comment 

period. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

extending the comment period for the 

draft guidance for Industry and Food 

and Drug Administration Staff entitled 

‘‘Public Notification of Emerging 

Postmarket Medical Device Signals 

(’Emerging Signals’).’’ A notice of the 

availability of the draft guidance and 

our request for comments appeared in 

the Federal Register of December 31, 

2015. We initially established February 

29, 2016, as the deadline for the 

submission of requested comments that 

can help improve the Agency’s policy 

for notifying the public about medical 

device ‘‘emerging signals.’’ The Agency 

is taking this action due to the 

unanticipated high-level of interest from 

external stakeholders and the medical 

device community and will allow 

interested persons additional time to 

submit comments. 

DATES: FDA is extending the comment 

period on the ‘‘Public Notification of 

Emerging Postmarket Medical Device 

Signals (’Emerging Signals’)’’; Draft 

Guidance for Industry and Food and 

Drug Administration Staff; Availability, 

which was announced in the Notice 

published December 31, 2015 (80 FR 

81829). 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on the draft guidance by March 29, 

2016. 

ADDRESSES: You may submit comments 

as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to http://

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 http://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’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Division of Dockets 

Management, 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 submissions received 

must include the Docket No. FDA– 

2015–D–4803 for ‘‘Public Notification of 

Emerging Postmarket Medical Device 

Signals (’Emerging Signals’).’’ Received 

comments will be placed in the docket 

and, except for those submitted as 

‘‘Confidential Submissions,’’ publicly 

viewable at http://www.regulations.gov 

or at the Division of Dockets 

Management 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 

comments only as a written/paper 

submission. 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 comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on http:// 

www.regulations.gov. Submit both 

copies to the Division of Dockets 

Management. 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 

comments 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 

comments to public dockets, see 80 FR 

56469, September 18, 2015, or access 

the information at: http://www.fda.gov/ 

regulatoryinformation/dockets/

default.htm. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to http://

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 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

An electronic copy of the draft 

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 ‘‘Public Notification 

of Emerging Postmarket Medical Device 

Signals (’Emerging Signals’)’’ 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 self-addressed adhesive label to 

assist that office in processing your 

request. 

FOR FURTHER INFORMATION CONTACT: 

Rebecca Nipper, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 1540, Silver Spring, 

MD 20993–0002, 301–796–6527. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of December 

31, 2015, FDA published a notice 

announcing the availability of a draft 

guidance entitled ‘‘Public Notification 

of Emerging Postmarket Medical Device 

Signals (’Emerging Signals’),’’ with a 60- 

day comment period to request 

comments on the Agency’s policy for 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 81, No. 17 / Wednesday, January 27, 2016 / Notices 4633 

notifying the public about medical 

device ‘‘emerging signals.’’ 

FDA is extending the comment period 

for the publication notification of 

‘‘emerging signals’’ for 30 days, until 

March 29, 2016. The Agency believes 

that a 30-day extension allows adequate 

time for interested persons to submit 

comments. 

II. 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 

Center for Devices and Radiological 

Health 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 ‘‘Public Notification of Emerging 

Postmarket Medical Device Signals 

(’Emerging Signals’)’’ may send an email 

request to CDRH-Guidance@fda.hhs.gov 

to receive an electronic copy of the 

document. Please use the document 

number 1500027 to identify the 

guidance you are requesting. 

Dated: January 21, 2016. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2016–01610 Filed 1–26–16; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Notice of Interest Rate on Overdue 

Debts 

Section 30.18 of the Department of 

Health and Human Services’ claims 

collection regulations (45 CFR part 30) 

provides that the Secretary shall charge 

an annual rate of interest, which is 

determined and fixed by the Secretary 

of the Treasury after considering private 

consumer rates of interest on the date 

that the Department of Health and 

Human Services becomes entitled to 

recovery. The rate cannot be lower than 

the Department of Treasury’s current 

value of funds rate or the applicable rate 

determined from the ‘‘Schedule of 

Certified Interest Rates with Range of 

Maturities’’ unless the Secretary waives 

interest in whole or part, or a different 

rate is prescribed by statute, contract, or 

repayment agreement. The Secretary of 

the Treasury may revise this rate 

quarterly. The Department of Health and 

Human Services publishes this rate in 

the Federal Register. 

The current rate of 93⁄4%, as fixed by 

the Secretary of the Treasury, is certified 

for the quarter ended December 31, 

2015. This rate is based on the Interest 

Rates for Specific Legislation, ‘‘National 

Health Services Corps Scholarship 

Program (42 U.S.C. 254o(b)(1)(A))’’ and 

‘‘National Research Service Award 

Program (42 U.S.C. 288(c)(4)(B)).’’ This 

interest rate will be applied to overdue 

debt until the Department of Health and 

Human Services publishes a revision. 

Dated: January 13, 2016. 

David C. Horn. 

Director, Office of Financial Policy and 

Reporting. 

[FR Doc. 2016–01649 Filed 1–26–16; 8:45 am] 

BILLING CODE 4150–04–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[CMS–9935–N2] 

HHS-Operated Risk Adjustment 

Methodology Meeting; March 31, 2016 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice of meeting. 

SUMMARY: This notice announces the 

rescheduling of the March 25, 2016 

meeting on the HHS-operated risk 

adjustment program, which is open to 

the public. The purpose of this 

stakeholder meeting is to solicit 

feedback on the HHS-operated risk 

adjustment methodology and to discuss 

potential improvements to the HHS risk 

adjustment methodology for the 2018 

benefit year and beyond. This meeting, 

the ‘‘HHS-operated Risk Adjustment 

Methodology Conference,’’ will allow 

issuers, States, and other interested 

parties to discuss the contents of a 

White Paper to be published in advance 

of this meeting. This meeting will also 

provide an opportunity for participants 

to ask clarifying questions. The 

comments and information HHS obtains 

through this meeting may be used in 

future policy making for the HHS risk 

adjustment program. 

DATES: Date of Meeting: March 31, 2016 

from 9:00 a.m. to 4:30 p.m., Eastern 

daylight time (e.d.t.). 

Deadline for Onsite Participation: 

March 23, 2016, 5:00 p.m., e.d.t. 

Deadline for Webinar Meeting 

Participation: March 28, 2016, 5:00 p.m. 

e.d.t. 

Deadline for Requesting Special 

Accommodations: March 23, 2016, 5:00 

p.m. e.d.t. 

ADDRESSES: The meeting will be held at 

the CMS Single Site campus, 7500 

Security Boulevard, Baltimore, MD 

21244. 

Registration: Registration will be on a 

first-come, first-serve basis, limited to 

two (2) participants per organization for 

the onsite location participation, and 

three (3) participants per organization 

for the webinar participation. Each 

individual can only register for either 

the onsite location participation or 

webinar participation. To change a 

registration option from onsite to 

webinar participation, the registrant 

must cancel the existing registration 

(onsite or webinar) before attempting to 

register for the other option. 

Registration Instructions: To register 

to attend the meeting either onsite or 

through webinar participation, visit the 

Registration for Technical Assistance 

Portal (REGTAP) at www.REGTAP.info. 

If not already a REGTAP user, register 

as a new user, log in and go to ‘‘My 

Dashboard’’ and select ‘‘Training 

Events’’ to register for the onsite or 

webinar event for the HHS-operated 

Risk Adjustment Methodology Meeting. 

Registrants can only register to attend 

the meeting onsite at CMS or remotely 

by webinar. 

FOR FURTHER INFORMATION CONTACT: For 

further information, please send 

inquiries about the logistics of the 

meeting to registrar@REGTAP.info. 

Users should submit inquiries and 

comments pertaining to content covered 

during the meeting to 

www.REGTAP.info. To submit an 

inquiry in REGTAP, select ‘‘Submit an 

Inquiry’’ from ‘‘My Dashboard’’ then 

select ‘‘HHS-operated Risk Adjustment 

Methodology Meeting’’ from the Event 

Title dropdown menu and enter the 

question or comment. Users can submit 

their comments and upload attachments 

as needed. REGTAP will send the user 

an acknowledgement upon receipt of 

the comment. 

The CCIIO’s Press Office at (202) 690– 

6145 will handle all press inquiries. 

SUPPLEMENTARY INFORMATION: 

I. Background 

This notice announces a meeting on 

the HHS-operated risk adjustment 

program to discuss potential 

improvements to the HHS risk 

adjustment methodology for the 2018 

benefit year and beyond. This meeting 

will focus on the permanent risk 

adjustment program under section 1343 

of the Affordable Care Act when HHS is 

operating a risk adjustment program on 

behalf of a State (referred to as the HHSoperated risk adjustment program). 

We are committed to stakeholder 

engagement in developing the detailed 

processes of the HHS-operated risk 


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