81 FR 8966 - Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Extension of Comment Period
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 35 (February 23, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 35 (February 23, 2016)
| Page Range | 8966-8967 | |
| FR Document | 2016-03696 |
[Federal Register Volume 81, Number 35 (Tuesday, February 23, 2016)] [Notices] [Pages 8966-8967] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-03696] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-D-4852] Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Extension of Comment Period AGENCY: Food and Drug Administration, HHS.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 provided in the notice entitled ``Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability'' that appeared in the Federal Register of January 26, 2016. That notice announced the availability of a draft guidance for industry and FDA staff and requested comments by March 28, 2016. FDA is extending the draft guidance's comment period by 30 days in response to requests for an extension to allow interested persons additional time to submit comments. DATES: FDA is extending the comment period for the draft guidance ``Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices'' published on January 26, 2016 (81 FR 4303), by an additional 30 days. 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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment of this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by April 28, 2016.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, [[Page 8967]] marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2015-D-4852 for ``Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices.'' 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 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 ``Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices'' 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; or the Office of Communication, Outreach, and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request. FOR FURTHER INFORMATION CONTACT: Heather Agler, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5570, Silver Spring, MD 20993-0002, 301-796-6340; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of January 26, 2016 (81 FR 4303), FDA published a notice announcing the availability of a draft guidance entitled ``Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices'' with a 60-day comment period to request comments. FDA is extending the comment period for the draft guidance for 30 days, until April 28, 2016. The Agency believes that a 30-day extension will allow 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.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or http://www.regulations.gov. Persons unable to download an electronic copy of ``Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices'' may send an email request to [email protected] to receive an electronic copy of the document. Please use the document number 1500015 to identify the guidance you are requesting. Dated: February 18, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-03696 Filed 2-22-16; 8:45 am] BILLING CODE 4164-01-P
![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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![Federal Register / Vol. 81, No. 35 / Tuesday, February 23, 2016 / Notices 8967
marked and identified, as confidential, information on electronic access to the of ‘‘Design Considerations and Pre-
if submitted as detailed in guidance. Submit written requests for a market Submission Recommendations
‘‘Instructions.’’ single hard copy of the draft guidance for Interoperable Medical Devices’’ may
Instructions: All submissions received document entitled ‘‘Design send an email request to CDRH-
must include the Docket No. FDA– Considerations and Pre-market Guidance@fda.hhs.gov to receive an
2015–D–4852 for ‘‘Design Submission Recommendations for electronic copy of the document. Please
Considerations and Pre-market Interoperable Medical Devices’’ to the use the document number 1500015 to
Submission Recommendations for Office of the Center Director, Guidance identify the guidance you are
Interoperable Medical Devices.’’ and Policy Development, Center for requesting.
Received comments will be placed in Devices and Radiological Health, Food Dated: February 18, 2016.
the docket and, except for those and Drug Administration, 10903 New Leslie Kux,
submitted as ‘‘Confidential Hampshire Ave., Bldg. 66, Rm. 5431,
Submissions,’’ publicly viewable at Associate Commissioner for Policy.
Silver Spring, MD 20993–0002; or the
http://www.regulations.gov or at the [FR Doc. 2016–03696 Filed 2–22–16; 8:45 am]
Office of Communication, Outreach, and
Division of Dockets Management Development, Center for Biologics BILLING CODE 4164–01–P
between 9 a.m. and 4 p.m., Monday Evaluation and Research, Food and
through Friday. Drug Administration, 10903 New
• Confidential Submissions—To Hampshire Ave., Bldg. 71, Rm. 3128,
DEPARTMENT OF HEALTH AND
submit a comment with confidential HUMAN SERVICES
Silver Spring, MD 20993–0002. Send
information that you do not wish to be one self-addressed adhesive label to
made publicly available, submit your Food and Drug Administration
assist that office in processing your
comments only as a written/paper request. [Docket No. FDA–2016–N–0173]
submission. You should submit two
copies total. One copy will include the FOR FURTHER INFORMATION CONTACT: Waterpipes and Waterpipe Tobacco;
information you claim to be confidential Heather Agler, Center for Devices and Public Workshop; Establishment of a
with a heading or cover note that states Radiological Health, Food and Drug Public Docket
‘‘THIS DOCUMENT CONTAINS Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5570, Silver Spring, AGENCY: Food and Drug Administration,
CONFIDENTIAL INFORMATION.’’ The HHS.
Agency will review this copy, including MD 20993–0002, 301–796–6340; or
the claimed confidential information, in Stephen Ripley, Center for Biologics ACTION: Notice of public workshop;
its consideration of comments. The Evaluation and Research, Food and establishment of docket; request for
second copy, which will have the Drug Administration, 10903 New comments.
claimed confidential information Hampshire Ave., Bldg. 71, Rm. 7301, SUMMARY: The Food and Drug
redacted/blacked out, will be available Silver Spring, MD 20993–0002, 240– Administration (FDA), Center for
for public viewing and posted on 402–7911. Tobacco Products (CTP), is announcing
http://www.regulations.gov. Submit SUPPLEMENTARY INFORMATION: a public workshop to gather scientific
both copies to the Division of Dockets information on waterpipes and
I. Background
Management. If you do not wish your waterpipe tobacco and to identify areas
name and contact information to be In the Federal Register of January 26, of research that may inform CTP’s
made publicly available, you can 2016 (81 FR 4303), FDA published a regulation of these tobacco products.
provide this information on the cover notice announcing the availability of a The workshop will include
sheet and not in the body of your draft guidance entitled ‘‘Design presentations and panel discussions
comments and you must identify this Considerations and Premarket about the current state of the science,
information as ‘‘confidential.’’ Any Submission Recommendations for and will focus on product use and
information marked as ‘‘confidential’’ Interoperable Medical Devices’’ with a design, smoke constituents,
will not be disclosed except in 60-day comment period to request environmental impacts, and the impact
accordance with 21 CFR 10.20 and other comments. FDA is extending the of marketing these products on
applicable disclosure law. For more comment period for the draft guidance population health, including on both
information about FDA’s posting of for 30 days, until April 28, 2016. The users and nonusers. FDA is also opening
comments to public dockets, see 80 FR Agency believes that a 30-day extension a public docket to receive data,
56469, September 18, 2015, or access will allow adequate time for interested information, and comments on this
the information at: http://www.fda.gov/ persons to submit comments. topic.
regulatoryinformation/dockets/
II. Electronic Access DATES: The public workshop will be
default.htm.
Docket: For access to the docket to Persons interested in obtaining a copy held on March 17, 2016, from 8:30 a.m.
read background documents or the of the draft guidance may do so by to 5 p.m. and on March 18, 2016, from
electronic and written/paper comments downloading an electronic copy from 8:30 a.m. to 4 p.m. Individuals who
received, go to http:// the Internet. A search capability for all wish to attend the public workshop
www.regulations.gov and insert the Center for Devices and Radiological must register by February 25, 2016.
docket number, found in brackets in the Health guidance documents is available Submit written or electronic comments
heading of this document, into the at http://www.fda.gov/MedicalDevices/ to Docket No. FDA–2016–N–0173 by
April 29, 2016.
mstockstill on DSK4VPTVN1PROD with NOTICES
‘‘Search’’ box and follow the prompts DeviceRegulationandGuidance/
and/or go to the Division of Dockets GuidanceDocuments/default.htm. ADDRESSES: The public workshop will
Management, 5630 Fishers Lane, Rm. Guidance documents are also available be held at the FDA White Oak Campus,
1061, Rockville, MD 20852. at http://www.fda.gov/BiologicsBlood 10903 New Hampshire Ave., Bldg. 31
An electronic copy of the guidance Vaccines/GuidanceCompliance Conference Center, the Great Room (Rm.
document is available for download RegulatoryInformation/default.htm or 1503A), Silver Spring, MD 20993.
from the Internet. See the http://www.regulations.gov. Persons Entrance for the public workshop
SUPPLEMENTARY INFORMATION section for unable to download an electronic copy participants (non-FDA employees) is
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Document Created: 2018-02-02 14:33:43
Document Modified: 2018-02-02 14:33:43
| 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; extension of comment period. | |
| Dates | FDA is extending the comment period for the draft guidance ``Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices'' published on January 26, 2016 (81 FR 4303), by an additional 30 days. 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 April 28, 2016. | |
| Contact | Heather Agler, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5570, Silver Spring, MD 20993-0002, 301-796-6340; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. | |
| FR Citation | 81 FR 8966 |
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