81 FR 8963 - Medicare Program; Public Meetings in Calendar Year 2016 for All New Public Requests for Revisions to the Healthcare Common Procedure Coding System (HCPCS) Coding and Payment Determinations
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 81, Issue 35 (February 23, 2016)
Centers for Medicare & Medicaid Services
Federal Register Volume 81, Issue 35 (February 23, 2016)
| Page Range | 8963-8966 | |
| FR Document | 2016-03703 |
[Federal Register Volume 81, Number 35 (Tuesday, February 23, 2016)] [Notices] [Pages 8963-8966] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-03703] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-1637-N] Medicare Program; Public Meetings in Calendar Year 2016 for All New Public Requests for Revisions to the Healthcare Common Procedure Coding System (HCPCS) Coding and Payment Determinations AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: This notice announces the dates, time, and location of the Healthcare Common Procedure Coding System (HCPCS) public meetings to be held in calendar year 2016 to discuss our preliminary coding and payment determinations for all new public requests for revisions to the HCPCS. These meetings provide a forum for interested parties to make oral presentations or to submit written comments in response to preliminary coding and payment determinations. The discussion will be focused on responses to our specific preliminary recommendations and will include all items on the public meeting agenda. As indicated in this notice, we are reorganizing public meeting content under two main headings: (1) Drugs/Biologics, Radiopharmaceuticals/Radiologic Imaging Agents, and (2) Durable Medical Equipment (DME) and Accessories; Orthotics and Prosthetics (O & P); Supplies and Other. DATES: Meeting Dates: The following are the 2016 HCPCS public meeting dates: 1. Tuesday, May 17, 2016, 9:00 a.m. to 5:00 p.m., eastern daylight time (e.d.t.) (Drugs/Biologicals, Radiopharmaceuticals/Radiologic Imaging Agents). 2. Wednesday, May 18, 2016, 9:00 a.m. to 5:00 p.m., e.d.t. (Drugs/ Biologicals, Radiopharmaceuticals/Radiologic Imaging Agents). 3. Thursday, May 19, 2016, 9:00 a.m. to 5:00 p.m., e.d.t. (Drugs/ Biologicals, Radiopharmaceuticals/Radiologic Imaging Agents). 4. Wednesday, June 1, 2016, 9:00 a.m. to 5:00 p.m., e.d.t. (Durable Medical Equipment (DME) and Accessories; Orthotics and Prosthetics (O & P); Supplies and Other). 5. Thursday, June 2, 2016, 9:00 a.m. to 5:00 p.m., e.d.t. (Durable Medical Equipment (DME) and Accessories; Orthotics and Prosthetics (O & P); Supplies and Other). Deadlines for Primary Speaker Registration and Presentation Materials: The deadline for registering to be a primary speaker and submitting materials and writings that will be used in support of an oral presentation are as follows:May 3, 2016 for the May 17, 2016, May 18, 2016 and May 19, 2016 public meetings. May 18, 2016 for the June 1, 2016 and June 2, 2016 public meetings. Registration Deadline for Attendees that are Foreign Nationals: All Foreign National visitors must present a valid passport as proof of identification. Attendees that are foreign nationals (as described in section IV. of this notice) are required to identify themselves as such, and provide the necessary information for security clearance (as described in section IV. of this notice) to the public meeting coordinator at least 21 business days in advance of the date of the public meeting the individual plans to attend. Therefore, the registration deadlines for attendees that are foreign nationals are as follows: April 28, 2016 for the May 17, 2016, May 18, 2016 and May 19, 2016 public meetings. May 12, 2016 for the June 1, 2016 and June 2, 2016 public meetings. Registration Deadlines for all Other Attendees: All individuals who are not foreign nationals who plan to enter the building to attend the public meeting must register for each date that they plan on attending. The registration [[Page 8964]] deadlines are different for each meeting. Registration deadlines are as follows: May 10, 2016 for the May 17, 2016, May 18, 2016 and May 19, 2016 public meetings. May 24, 2016 for the June 1, 2016 and June 2, 2016 public meeting dates. Deadlines for Requesting Special Accommodations: Individuals who plan to attend the public meetings and require sign-language interpretation or other special assistance must request these services at least two weeks in advance of the meeting date, by the following deadlines: May 3, 2016 for the May 17, 2016, May 18, 2016 and May 19, 2016 public meetings. May 18, 2016 for the June 1, 2016 and June 2, 2016 public meetings. Requests for Special Accommodation may be made within the on-line registration located at www.cms.hhs.gov/medhcpcsgeninfo or by contacting Judi Wallace at (410) 786-3197 or [email protected] or Nathan Helman at (410) 786-4602 or [email protected]. When a request for Special Accommodations is made separate from the on-line registration, it is also necessary to complete the online registration to gain access to the facility. Deadline for Submission of Written Comments: Written comments and other documentation in response to a preliminary coding or payment determination that are received by no later than the date of the public meeting at which the code request is scheduled for discussion, will be considered in formulating a final coding decision. ADDRESSES: Meeting Location: The public meetings will be held in the main auditorium of the central building of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244-1850. Submission of Written Comments: Written comments may either be emailed to [email protected] or [email protected] or sent via regular mail to Judi Wallace or Nathan Helman, HCPCS Public Meeting Coordinators, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Mail Stop C5-09-14, Baltimore, MD 21244-1850. FOR FURTHER INFORMATION CONTACT: Judi Wallace at (410)786-3197 or [email protected]. SUPPLEMENTARY INFORMATION: I. Background On December 21, 2000, the Congress passed the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA) (Pub. L. 106-554). Section 531(b) of BIPA mandated that we establish procedures that permit public consultation for coding and payment determinations for new durable medical equipment (DME) under Medicare Part B of title XVIII of the Social Security Act (the Act). In the November 23, 2001 Federal Register (66 FR 58743), we published a notice providing information regarding the establishment of the public meeting process for DME. The procedures and public meetings announced in this notice for new DME are in response to the mandate of section 531(b) of BIPA. As part of HCPCS reform, we expanded the public meeting forum to include all public requests as of the 2005-2006 coding cycle (70 FR 15340, March 25, 2005). It is our intent to distribute any materials submitted to us to the HCPCS workgroup members for their consideration. CMS and the HCPCS workgroup members require sufficient preparation time to review all relevant materials. Therefore, we are implementing a 10-page submission limit and firm deadlines for receipt of any presentation materials a meeting speaker wishes us to consider. For this reason, our HCPCS Public Meeting Coordinator will only accept and review presentation materials received by the deadline for each public meeting, as specified in the DATES section of this notice. II. Meeting Registration A. Required Information for Registration The following information must be provided when registering: Name. Company name and address. Direct-dial telephone and fax numbers. Email address. Special needs information. A CMS staff member will confirm your registration by email. B. Registration Process 1. Primary Speakers Individuals must also indicate whether they are the ``primary speaker'' for an agenda item. Primary speakers must be designated by the entity that submitted the HCPCS coding request. When registering, primary speakers must provide a brief written statement regarding the nature of the information they intend to provide, and advise the HCPCS Public Meeting Coordinator regarding needs for audio/visual support. To avoid disruption of the meeting and ensure compatibility with our systems, tapes and disk files are tested and arranged in speaker sequence well in advance of the meeting. We will accept tapes and disk files that are received by the deadline for submissions for each public meeting as specified in the DATES section of this notice. Late submissions and updates of electronic materials after our deadline cannot be accommodated. Please note CMS' page limit for primary speaker presentation materials. The sum of all presentation materials and additional supporting documentation may not exceed 10 pages (each side of a page counts as 1 page). An exception will be made to the 10-page limit only for relevant studies newly published between the application deadline and the public meeting date, in which case, we would like a copy of the complete publication as soon as possible. This exception applies only to the page limit and not the submission deadline. The materials may be emailed or delivered by regular mail to the HCPCS Public Meeting Coordinators as specified in the ADDRESSES section of this notice. The materials must be emailed or postmarked no later than the deadline specified in the DATES section of this notice. Individuals will need to provide 35 copies if materials are delivered by mail. 2. ``5-Minute Speakers'' To afford the same opportunity to all attendees, 5-minute speakers are not required to register as primary speakers. However, 5-minute speakers must still register as attendees by the deadline set forth under ``Registration Deadlines for all Other Attendees'' in the DATES section of this notice. Attendees can sign up only on the day of the meeting to do a presentation of up to 5 minutes. Individuals must provide their name, company name and address, contact information as specified on the sign-up sheet, and identify the specific agenda item that they will address. C. Additional Meeting/Registration Information Please note that all of the CMS' 2016 HCPCS public meetings will begin at 9:00 a.m. each day as noted in the DATES section of this notice. The product category reported in the HCPCS code application by the applicant may not be the same as that assigned by us. Prior to registering to attend a public meeting, all participants are advised to review the public meeting agendas at www.cms.hhs.gov/medhcpcsgeninfo which identify our category determinations, and the dates each item will be discussed. Draft agendas, including a summary of each [[Page 8965]] request and our preliminary decision will be posted on our HCPCS Web site at www.cms.hhs.gov/medhcpcsgeninfo at least 4 weeks before each meeting. Additional details regarding the public meeting process for all new public requests for revisions to the HCPCS, along with information on how to register and guidelines for an effective presentation, will be posted at least 4 weeks before the first meeting date on the official HCPCS Web site at www.cms.hhs.gov/medhcpcsgeninfo. The document titled ``Guidelines for Participation in Public Meetings for All New Public Requests for Revisions to the Healthcare Common Procedure Coding System (HCPCS)'' will be made available on the HCPCS Web site at least 4 weeks before the first public meeting in 2016 for all new public requests for revisions to the HCPCS. Individuals who intend to provide a presentation at a public meeting need to familiarize themselves with the HCPCS Web site and the valuable information it provides to prospective registrants. The HCPCS Web site also contains a document titled ``Healthcare Common Procedure Coding System (HCPCS) Level II Coding Procedures,'' which is a description of the HCPCS coding process, including a detailed explanation of the procedures used to make coding determinations for all the products, supplies, and services that are coded in the HCPCS. The HCPCS Web site also contains a document titled ``HCPCS Decision Tree & Definitions'' which illustrates, in flow diagram format, HCPCS coding standards as described in our Coding Procedures document. A summary of each public meeting will be posted on the HCPCS Web site by the end of August 2016. III. Presentations and Comment Format We can only estimate the amount of meeting time that will be needed since it is difficult to anticipate the total number of speakers that will register for each meeting. Meeting participants should arrive early to allow time to clear security and sign-in. Each meeting is expected to begin promptly as scheduled. Meetings may end earlier than the stated ending time. A. Oral Presentation Procedures All primary speakers must register as provided under the section titled ``Meeting Registration.'' Materials and writings that will be used in support of an oral presentation should be submitted to the HCPCS Public Meeting Coordinator. The materials may be emailed or delivered by regular mail to the HCPCS Public Meeting Coordinator as specified in the ADDRESSES section of this notice. The materials must be emailed or postmarked no later than the deadline specified in the DATES section of this notice. Individuals will need to include 35 copies if materials are delivered by mail. B. Primary Speaker Presentations The individual or entity requesting revisions to the HCPCS coding system for a particular agenda item may designate one ``primary speaker'' to make a presentation for a maximum of 15 minutes. Fifteen minutes is the total time interval for the presentation, and the presentation must incorporate any demonstration, set-up, and distribution of material. In establishing the public meeting agenda, we may group multiple, related requests under the same agenda item. In that case, we will decide whether additional time will be allotted, and may opt to increase the amount of time allotted to the speaker by increments of less than 15 minutes. Individuals designated to be the primary speaker must register to attend the meeting using the registration procedures described under the ``Meeting Registration'' section of this notice and contact one of the HCPCS Public Meeting Coordinators, specified in the ADDRESSES section. Primary speakers must also separately register as primary speakers by the date specified in the DATES section of this notice. C. ``5-Minute'' Speaker Presentations Meeting attendees can sign up at the meeting, on a first-come, first-served basis, to make presentations for up to 5 minutes on individual agenda items. Based on the number of items on the agenda and the progress of the meeting, a determination will be made at the meeting by the meeting coordinator and the meeting moderator regarding how many ``5-minute speakers'' can be accommodated and/or whether the 5-minute time allocation would be reduced, to accommodate the number of speakers. D. Speaker Declaration On the day of the meeting, before the end of the meeting, all primary speakers and 5-minute speakers must provide a brief written summary of their comments and conclusions to the HCPCS Public Meeting Coordinator. Every primary speaker and 5-minute speaker must declare at the beginning of their presentation at the meeting, as well as in their written summary, whether they have any financial involvement with the manufacturers or competitors of any items being discussed; this includes any payment, salary, remuneration, or benefit provided to that speaker by the manufacturer or the manufacturer's representatives. E. Written Comments From Meeting Attendees Written comments will be accepted from the general public and meeting registrants anytime up to the date of the public meeting at which a request is discussed. Comments must be sent to the address listed in the ADDRESSES section of this notice. Meeting attendees may also submit their written comments at the meeting. Due to the close timing of the public meetings, subsequent workgroup reconsiderations, and final decisions, we are able to consider only those comments received in writing by the close of the public meeting at which the request is discussed. IV. Security, Building, and Parking Guidelines The meetings are held within the CMS Complex which is not open to the general public. Visitors to the complex are required to show a valid Government issued photo identification at the time of entry. As of October, 10, 2015, visitors seeking access to federal agency facilities using their state-issued driver's license or identification cards must present proper identification issued by a state that is compliant with the REAL ID Act of 2005, (Pub. L. 109-13, 119 Statute 302, enacted on May 11, 2005), or a state that has received an extension. What constitutes proper identification and whether a driver's license is acceptable identification for accessing a federal facility may vary, based on which state issued the driver's license. For detailed information, please refer to the Department of Homeland Security (DHS) Web site at http://www.dhs.gov. When planning to visit a federal facility, visitors who have further questions about acceptable forms of identification are encouraged to contact the facility to determine acceptable identification. In addition, all Foreign National visitors must present a valid passport as proof of identification. Visitors will also be subject to a vehicle security inspection before access to the complex is granted. Participants not in possession of a valid identification or who are in possession of prohibited items will be denied access to the complex. Prohibited items on federal property include but are not limited to, alcoholic beverages, illegal narcotics, explosives, firearms or other dangerous weapons (including pocket knives), dogs or other animals except [[Page 8966]] service animals. Once cleared for entry to the complex participants will be directed to visitor parking by a security officer. To ensure expedited entry into the building it is recommended that participants have their government ID and a copy of their written meeting registration confirmation readily available and that they do not bring large/bulky items into the building. Participants are reminded that photography on the CMS complex is prohibited. CMS has also been declared a tobacco free campus and violators are subject to legal action. In planning arrival time, we recommend allowing additional time to clear security. Individuals who are not registered in advance will not be permitted to enter the building and will be unable to attend the meeting. The invited guests may not enter the building earlier than 45 minutes before the convening of the meeting each day. Guest access to the complex is limited to the meeting area, the main entrance lobby, and the cafeteria. If a visitor is found outside of those areas without proper escort they may be escorted off of the premises. Also be mindful that there will be an opportunity for everyone to speak and we request that everyone waits for the appropriate time to present their product or opinions. Disruptive behavior will not be tolerated and may result in removal from the meetings and escort from the complex. No visitor is allowed to attach USB cables, thumb drives or any other equipment to any CMS information technology (IT) system or hardware for any purpose at any time. Additionally, CMS staff is prohibited from taking such actions on behalf of a visitor or utilizing any removable media provided by a visitor. We cannot assume responsibility for coordinating the receipt, transfer, transport, storage, set-up, safety, or timely arrival of any personal belongings or items used for demonstration or to support a presentation. Special arrangements and approvals are required at least 2 weeks prior to each public meeting to bring pieces of equipment or medical devices. These arrangements need to be made with the public meeting coordinator. It is possible that certain requests made in advance of the public meeting could be denied because of unique safety, security or handling issues related to the equipment. A minimum of 2 weeks is required for approvals and security procedures. Any request not submitted at least 2 weeks in advance of the public meeting will be denied. Foreign National Visitors are defined as Non-US Citizens, and non- lawful permanent residents, non-resident aliens or non-green-card holders. Attendees that are foreign nationals must identify themselves as such, and provide the following information for security clearance to the public meeting coordinator by the date specified in the DATES section of this notice: Building to Visit/Destination. Visit start date, start time, end date, end time. Visitor full name. Gender. Visitor Title. Visitor Organization/Employer. Citizenship. Birth Place (City, Country). Date of Birth. ID Type (Passport or State Department ID). Passport issued by Country. ID (passport) Number. ID (passport) issue date. ID (passport) expiration date. Visa Type. Visa Number. Purpose of Visit. Dated: February 2, 2016. Andrew M. Slavitt, Acting Administrator, Centers for Medicare & Medicaid Services. [FR Doc. 2016-03703 Filed 2-22-16; 8:45 am] BILLING CODE 4120-01-P
![Federal Register / Vol. 81, No. 35 / Tuesday, February 23, 2016 / Notices 8963
number. Each participant will receive interactive features will not be stored in objective and quantifiable measure that
up to two survey reminders starting one the system. The database only collects tracks and records participants’
week after the initial survey link is sent, web analytics data about page visits and exposure to Crush. This study
for two consecutive weeks. There are duration of each visit by User component does not entail any response
minor differences in survey content for Identification (ID) and Internet Protocol burden to participants.
the control and intervention groups. (IP) address. Web analytics will only be Findings will be used to inform the
Each participant will create a profile collected from participants navigating
in the database upon enrollment. This development and delivery of effective
Crush and only when they are logged in health communications.
database will collect initial
as users. Web analytics are generated for OMB approval is requested for one
demographic and contact information,
any Web site and are a standard year. Participation is voluntary and
informed consent signatures, and
information about the participant’s evaluation mechanism for assessing the there are no costs to respondents other
navigation pattern through Crush. Any traffic patterns on Web pages. This than their time. The total estimated
information entered directly into Crush technology permits development of an annualized burden hours are 802.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of Avg. burden
Number of
Type of respondents Form name responses per per response
respondents respondent (in hrs.)
Girls 14–18 years old ...................................... Screener Questions ....................................... 3,000 1 1/60
Enrollment Questions ..................................... 1,200 1 5/60
Intervention Group .......................................... Baseline Survey ............................................. 600 1 15/60
3-Month Survey .............................................. 480 1 10/60
6-Month Survey .............................................. 384 1 15/60
Control Group ................................................. Baseline Survey ............................................. 600 1 15/60
3-Month Survey .............................................. 480 1 10/60
6-Month Survey .............................................. 384 1 15/60
Leroy A. Richardson, coding and payment determinations. Deadlines for Primary Speaker
Chief, Information Collection Review Office, The discussion will be focused on Registration and Presentation Materials:
Office of Scientific Integrity, Office of the responses to our specific preliminary The deadline for registering to be a
Associate Director for Science, Office of the recommendations and will include all primary speaker and submitting
Director, Centers for Disease Control and items on the public meeting agenda. As materials and writings that will be used
Prevention.
indicated in this notice, we are in support of an oral presentation are as
[FR Doc. 2016–03687 Filed 2–22–16; 8:45 am]
reorganizing public meeting content follows:
BILLING CODE 4163–18–P under two main headings: (1) Drugs/ • May 3, 2016 for the May 17, 2016,
Biologics, Radiopharmaceuticals/ May 18, 2016 and May 19, 2016 public
Radiologic Imaging Agents, and (2) meetings.
DEPARTMENT OF HEALTH AND • May 18, 2016 for the June 1, 2016
Durable Medical Equipment (DME) and
HUMAN SERVICES and June 2, 2016 public meetings.
Accessories; Orthotics and Prosthetics
Centers for Medicare & Medicaid (O & P); Supplies and Other. Registration Deadline for Attendees
Services DATES: Meeting Dates: The following are
that are Foreign Nationals: All Foreign
the 2016 HCPCS public meeting dates: National visitors must present a valid
[CMS–1637–N] passport as proof of identification.
1. Tuesday, May 17, 2016, 9:00 a.m.
Attendees that are foreign nationals (as
Medicare Program; Public Meetings in to 5:00 p.m., eastern daylight time
described in section IV. of this notice)
Calendar Year 2016 for All New Public (e.d.t.) (Drugs/Biologicals,
are required to identify themselves as
Requests for Revisions to the Radiopharmaceuticals/Radiologic
such, and provide the necessary
Healthcare Common Procedure Coding Imaging Agents).
information for security clearance (as
System (HCPCS) Coding and Payment 2. Wednesday, May 18, 2016, 9:00 described in section IV. of this notice)
Determinations a.m. to 5:00 p.m., e.d.t. (Drugs/ to the public meeting coordinator at
Biologicals, Radiopharmaceuticals/ least 21 business days in advance of the
AGENCY: Centers for Medicare &
Radiologic Imaging Agents). date of the public meeting the
Medicaid Services (CMS), HHS.
3. Thursday, May 19, 2016, 9:00 a.m. individual plans to attend. Therefore,
ACTION: Notice.
to 5:00 p.m., e.d.t. (Drugs/Biologicals, the registration deadlines for attendees
SUMMARY: This notice announces the Radiopharmaceuticals/Radiologic that are foreign nationals are as follows:
dates, time, and location of the Imaging Agents). • April 28, 2016 for the May 17, 2016,
Healthcare Common Procedure Coding 4. Wednesday, June 1, 2016, 9:00 a.m. May 18, 2016 and May 19, 2016 public
System (HCPCS) public meetings to be to 5:00 p.m., e.d.t. (Durable Medical meetings.
Equipment (DME) and Accessories; • May 12, 2016 for the June 1, 2016
mstockstill on DSK4VPTVN1PROD with NOTICES
held in calendar year 2016 to discuss
our preliminary coding and payment Orthotics and Prosthetics (O & P); and June 2, 2016 public meetings.
determinations for all new public Supplies and Other). Registration Deadlines for all Other
requests for revisions to the HCPCS. 5. Thursday, June 2, 2016, 9:00 a.m. Attendees: All individuals who are not
These meetings provide a forum for to 5:00 p.m., e.d.t. (Durable Medical foreign nationals who plan to enter the
interested parties to make oral Equipment (DME) and Accessories; building to attend the public meeting
presentations or to submit written Orthotics and Prosthetics (O & P); must register for each date that they
comments in response to preliminary Supplies and Other). plan on attending. The registration
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![8966 Federal Register / Vol. 81, No. 35 / Tuesday, February 23, 2016 / Notices
service animals. Once cleared for entry Foreign National Visitors are defined FDA is extending the draft guidance’s
to the complex participants will be as Non-US Citizens, and non-lawful comment period by 30 days in response
directed to visitor parking by a security permanent residents, non-resident to requests for an extension to allow
officer. aliens or non-green-card holders. interested persons additional time to
To ensure expedited entry into the Attendees that are foreign nationals submit comments.
building it is recommended that must identify themselves as such, and DATES: FDA is extending the comment
participants have their government ID provide the following information for period for the draft guidance ‘‘Design
and a copy of their written meeting security clearance to the public meeting Considerations and Premarket
registration confirmation readily coordinator by the date specified in the Submission Recommendations for
available and that they do not bring DATES section of this notice: Interoperable Medical Devices’’
large/bulky items into the building. • Building to Visit/Destination. published on January 26, 2016 (81 FR
Participants are reminded that • Visit start date, start time, end date, 4303), by an additional 30 days.
photography on the CMS complex is end time. Although you can comment on any
prohibited. CMS has also been declared • Visitor full name. guidance at any time (see 21 CFR
a tobacco free campus and violators are • Gender. 10.115(g)(5)), to ensure that the Agency
subject to legal action. In planning • Visitor Title. considers your comment of this draft
arrival time, we recommend allowing • Visitor Organization/Employer.
guidance before it begins work on the
additional time to clear security. • Citizenship.
• Birth Place (City, Country). final version of the guidance, submit
Individuals who are not registered in either electronic or written comments
• Date of Birth.
advance will not be permitted to enter on the draft guidance by April 28, 2016.
• ID Type (Passport or State
the building and will be unable to ADDRESSES: You may submit comments
Department ID).
attend the meeting. The invited guests
• Passport issued by Country. as follows:
may not enter the building earlier than • ID (passport) Number.
45 minutes before the convening of the Electronic Submissions
• ID (passport) issue date.
meeting each day. • ID (passport) expiration date. Submit electronic comments in the
Guest access to the complex is limited • Visa Type. following way:
to the meeting area, the main entrance • Visa Number. • Federal eRulemaking Portal: http://
lobby, and the cafeteria. If a visitor is • Purpose of Visit. www.regulations.gov. Follow the
found outside of those areas without instructions for submitting comments.
Dated: February 2, 2016.
proper escort they may be escorted off Comments submitted electronically,
Andrew M. Slavitt,
of the premises. Also be mindful that including attachments, to http://
there will be an opportunity for Acting Administrator, Centers for Medicare
& Medicaid Services. www.regulations.gov will be posted to
everyone to speak and we request that the docket unchanged. Because your
everyone waits for the appropriate time [FR Doc. 2016–03703 Filed 2–22–16; 8:45 am]
comment will be made public, you are
to present their product or opinions. BILLING CODE 4120–01–P
solely responsible for ensuring that your
Disruptive behavior will not be tolerated comment does not include any
and may result in removal from the confidential information that you or a
meetings and escort from the complex. DEPARTMENT OF HEALTH AND
HUMAN SERVICES third party may not wish to be posted,
No visitor is allowed to attach USB such as medical information, your or
cables, thumb drives or any other Food and Drug Administration anyone else’s Social Security number, or
equipment to any CMS information confidential business information, such
technology (IT) system or hardware for [Docket No. FDA–2015–D–4852] as a manufacturing process. Please note
any purpose at any time. Additionally, that if you include your name, contact
CMS staff is prohibited from taking such Design Considerations and Premarket
information, or other information that
actions on behalf of a visitor or utilizing Submission Recommendations for
identifies you in the body of your
any removable media provided by a Interoperable Medical Devices; Draft
comments, that information will be
visitor. Guidance for Industry and Food and
posted on http://www.regulations.gov.
Drug Administration Staff; Extension
We cannot assume responsibility for • If you want to submit a comment
coordinating the receipt, transfer, of Comment Period
with confidential information that you
transport, storage, set-up, safety, or AGENCY: Food and Drug Administration, do not wish to be made available to the
timely arrival of any personal HHS. public, submit the comment as a
belongings or items used for ACTION: Notice; extension of comment written/paper submission and in the
demonstration or to support a period. manner detailed (see ‘‘Written/Paper
presentation. Special arrangements and Submissions’’ and ‘‘Instructions’’).
approvals are required at least 2 weeks SUMMARY: The Food and Drug
prior to each public meeting to bring Administration (FDA or Agency) is Written/Paper Submissions
pieces of equipment or medical devices. extending the comment period provided Submit written/paper submissions as
These arrangements need to be made in the notice entitled ‘‘Design follows:
with the public meeting coordinator. It Considerations and Pre-market • Mail/Hand delivery/Courier (for
is possible that certain requests made in Submission Recommendations for written/paper submissions): Division of
mstockstill on DSK4VPTVN1PROD with NOTICES
advance of the public meeting could be Interoperable Medical Devices; Draft Dockets Management (HFA–305), Food
denied because of unique safety, Guidance for Industry and Food and and Drug Administration, 5630 Fishers
security or handling issues related to the Drug Administration Staff; Availability’’ Lane, Rm. 1061, Rockville, MD 20852.
equipment. A minimum of 2 weeks is that appeared in the Federal Register of • For written/paper comments
required for approvals and security January 26, 2016. That notice submitted to the Division of Dockets
procedures. Any request not submitted announced the availability of a draft Management, FDA will post your
at least 2 weeks in advance of the public guidance for industry and FDA staff and comment, as well as any attachments,
meeting will be denied. requested comments by March 28, 2016. except for information submitted,
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Document Created: 2018-02-02 14:33:20
Document Modified: 2018-02-02 14:33:20
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Meeting Dates: The following are the 2016 HCPCS public meeting dates: | |
| Contact | Judi Wallace at (410)786-3197 or [email protected] | |
| FR Citation | 81 FR 8963 |
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