81_FR_37715 81 FR 37603 - Dissemination of Patient-Specific Information From Devices by Device Manufacturers; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

81 FR 37603 - Dissemination of Patient-Specific Information From Devices by Device Manufacturers; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 112 (June 10, 2016)

Page Range37603-37604
FR Document2016-13787

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Dissemination of Patient-Specific Information from Devices by Device Manufacturers.'' The FDA developed this draft guidance to facilitate the appropriate and responsible dissemination of patient-specific information recorded, stored, processed, retrieved, and/or derived from medical devices from manufacturers to patients. This draft guidance provides recommendations to industry, healthcare providers, and FDA staff about the mechanisms and considerations for device manufacturers sharing such information with patients. This draft guidance is not final nor is it in effect at this time.

Federal Register, Volume 81 Issue 112 (Friday, June 10, 2016) 
[Federal Register Volume 81, Number 112 (Friday, June 10, 2016)]
[Notices]
[Pages 37603-37604]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-13787]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-1264]


Dissemination of Patient-Specific Information From Devices by 
Device Manufacturers; Draft Guidance for Industry and Food and Drug 
Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of the draft guidance entitled ``Dissemination of 
Patient-Specific Information from Devices by Device Manufacturers.'' 
The FDA developed this draft guidance to facilitate the appropriate and 
responsible dissemination of patient-specific information recorded, 
stored, processed, retrieved, and/or derived from medical devices from 
manufacturers to patients. This draft guidance provides recommendations 
to industry, healthcare providers, and FDA staff about the mechanisms 
and considerations for device manufacturers sharing such information 
with patients. This draft guidance is not final nor is it in effect at 
this time.

DATES: 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 August 9, 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.''

[[Page 37604]]

    Instructions: All submissions received must include the Docket No. 
FDA-2016-D-1264 for ``Dissemination of Patient-Specific Information 
from Devices by Device Manufacturers.'' 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 
``Dissemination of Patient-Specific Information from Devices by Device 
Manufacturers'' 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: Sugato De, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, rm. 5435, Silver Spring, MD 20993-0002, 301-796-6270, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Increasingly, patients seek to play an active role in their own 
healthcare. FDA believes that manufacturers providing patients with 
accurate, useable information about their healthcare (including the 
medical products they use and patient-specific information these 
products generate) will improve healthcare by empowering patients to 
participate fully with their healthcare providers in making sound 
medical decisions. For purposes of this guidance, patient-specific 
information is defined as any information unique to an individual 
patient or unique to that patient's treatment or diagnosis that may be 
recorded, stored, processed, retrieved, and/or derived from a medical 
device. This information may include, but is not limited to, recorded 
patient data, device usage/output statistics, healthcare provider 
inputs, incidence of alarms, and/or records of device malfunctions or 
failures.
    FDA developed this draft guidance to convey FDA's policy regarding 
the dissemination of patient-specific information recorded, stored, 
processed, retrieved, and/or derived from a medical device and provided 
by the manufacturer to the patient who is either treated or diagnosed 
with that specific device. This draft guidance document also outlines 
considerations for the form in which this information is communicated 
to help to ensure clarity of content and appropriate context.
    Manufacturers may share patient-specific information (recorded, 
stored, processed, retrieved, and/or derived from a medical device, 
consistent with the intended use of that medical device) with patients 
either on their own initiative or at the patient's request, without 
obtaining additional premarket review before doing so. Any labeling, as 
that term is defined in section 201(m) of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act), that is provided to the patient by the 
manufacturer is subject to applicable requirements in the FD&C Act and 
FDA regulations.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance when 
finalized will represent the current thinking of FDA on ``Dissemination 
of Patient-Specific Information from Devices by Device Manufacturers.'' 
It does not establish any rights for any person and is not binding on 
FDA or the public. You can use an alternative approach if it satisfies 
the requirements of the applicable statutes and regulations.

III. 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 ``Dissemination of Patient-
Specific Information from Devices by Device Manufacturers'' may send an 
email request to [email protected] to receive an electronic 
copy of the document. Please use the document number 1500067 to 
identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations and guidance. These collections of 
information are subject to review by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR parts 801 and 809, 
regarding device labeling, are approved under OMB control number 0910-
0485.

    Dated: June 6, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-13787 Filed 6-9-16; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 112 / Friday, June 10, 2016 / Notices 37603 TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of Number of Total annual Average burden per 21 CFR section and activity responses per Total hours respondents responses response respondent Medicated Feed Mill License Application using 20 1 20 0.25 (15 minutes) ...... 5 Form FDA 3448 (515.10(b)). Supplemental Feed Mill License Application using 40 1 40 0.25 (15 minutes) ...... 10 Form FDA 3448 (515.11(b)). Voluntary Revocation of Medicated Feed Mill Li- 40 1 40 0.25 (15 minutes) ...... 10 cense. (515.23) .................................................................... Filing a Request for a Hearing on Medicated Feed 1 1 1 4 ................................ 4 Mill License (515.30(c)). Total .................................................................. ........................ ........................ ........................ .................................... 29 1 There are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of Number of Total annual Average burden per 21 CFR section and activity records per Total hours recordkeepers records recordkeeping recordkeeper Maintenance of Records for Approved Labeling for 890 1 890 0.03 (2 minutes) ........ 27 Each ‘‘Type B’’ and ‘‘Type C’’ Feed (510.305). 1 There are no capital costs or operating and maintenance costs associated with this collection of information. These estimates are based on our SUMMARY: The Food and Drug the docket unchanged. Because your experience with medicated feed mill Administration (FDA or Agency) is comment will be made public, you are license applications. We estimate that announcing the availability of the draft solely responsible for ensuring that your we will receive 20 medicated feed mill guidance entitled ‘‘Dissemination of comment does not include any license applications, 40 supplemental Patient-Specific Information from confidential information that you or a applications, 40 requests for voluntary Devices by Device Manufacturers.’’ The third party may not wish to be posted, revocation, and that these submissions FDA developed this draft guidance to such as medical information, your or will take approximately 15 minutes per facilitate the appropriate and anyone else’s Social Security number, or response, as shown in table 1, rows 1 responsible dissemination of patient- confidential business information, such through 3. We estimate that preparing a specific information recorded, stored, as a manufacturing process. Please note request for a hearing under § 515.30(c) processed, retrieved, and/or derived that if you include your name, contact takes approximately 4 hours, as shown from medical devices from information, or other information that in table 1, row 4. In table 2, we estimate manufacturers to patients. This draft identifies you in the body of your that 890 licensees will keep the records guidance provides recommendations to comments, that information will be required by 21 CFR 510.305 expending industry, healthcare providers, and FDA posted on http://www.regulations.gov. a total of 27 hours annually. staff about the mechanisms and • If you want to submit a comment Dated: June 6, 2016. considerations for device manufacturers with confidential information that you Leslie Kux, sharing such information with patients. do not wish to be made available to the This draft guidance is not final nor is it public, submit the comment as a Associate Commissioner for Policy. in effect at this time. written/paper submission and in the [FR Doc. 2016–13790 Filed 6–9–16; 8:45 am] DATES: Although you can comment on manner detailed (see ‘‘Written/Paper BILLING CODE 4164–01–P any guidance at any time (see 21 CFR Submissions’’ and ‘‘Instructions’’). 10.115(g)(5)), to ensure that the Agency considers your comment of this draft Written/Paper Submissions DEPARTMENT OF HEALTH AND HUMAN SERVICES guidance before it begins work on the Submit written/paper submissions as final version of the guidance, submit follows: Food and Drug Administration either electronic or written comments on the draft guidance by August 9, 2016. • Mail/Hand delivery/Courier (for written/paper submissions): Division of [Docket No. FDA–2016–D–1264] ADDRESSES: You may submit comments Dockets Management (HFA–305), Food as follows: and Drug Administration, 5630 Fishers Dissemination of Patient-Specific Electronic Submissions Lane, Rm. 1061, Rockville, MD 20852. asabaliauskas on DSK3SPTVN1PROD with NOTICES Information From Devices by Device Manufacturers; Draft Guidance for Submit electronic comments in the • For written/paper comments Industry and Food and Drug following way: submitted to the Division of Dockets Administration Staff; Availability • Federal eRulemaking Portal: http:// Management, FDA will post your www.regulations.gov. Follow the comment, as well as any attachments, AGENCY: Food and Drug Administration, instructions for submitting comments. except for information submitted, HHS. Comments submitted electronically, marked and identified, as confidential, including attachments, to http:// if submitted as detailed in ACTION: Notice of availability. www.regulations.gov will be posted to ‘‘Instructions.’’ VerDate Sep<11>2014 19:02 Jun 09, 2016 Jkt 238001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\10JNN1.SGM 10JNN1

37604 Federal Register / Vol. 81, No. 112 / Friday, June 10, 2016 / Notices Instructions: All submissions received Patient-Specific Information from that term is defined in section 201(m) of must include the Docket No. FDA– Devices by Device Manufacturers’’ to the Federal Food, Drug, and Cosmetic 2016–D–1264 for ‘‘Dissemination of the Office of the Center Director, Act (the FD&C Act), that is provided to Patient-Specific Information from Guidance and Policy Development, the patient by the manufacturer is Devices by Device Manufacturers.’’ Center for Devices and Radiological subject to applicable requirements in Received comments will be placed in Health, Food and Drug Administration, the FD&C Act and FDA regulations. the docket and, except for those 10903 New Hampshire Ave., Bldg. 66, submitted as ‘‘Confidential Rm. 5431, Silver Spring, MD 20993– II. Significance of Guidance Submissions,’’ publicly viewable at 0002. Send one self-addressed adhesive http://www.regulations.gov or at the This draft guidance is being issued label to assist that office in processing Division of Dockets Management consistent with FDA’s good guidance your request. between 9 a.m. and 4 p.m., Monday practices regulation (21 CFR 10.115). FOR FURTHER INFORMATION CONTACT: through Friday. The draft guidance when finalized will Sugato De, Center for Devices and • Confidential Submissions—To Radiological Health, Food and Drug represent the current thinking of FDA submit a comment with confidential on ‘‘Dissemination of Patient-Specific Administration, 10903 New Hampshire information that you do not wish to be Ave., Bldg. 66, rm. 5435, Silver Spring, Information from Devices by Device made publicly available, submit your MD 20993–0002, 301–796–6270, Manufacturers.’’ It does not establish comments only as a written/paper Sugato.De@fda.hhs.gov. any rights for any person and is not submission. You should submit two binding on FDA or the public. You can SUPPLEMENTARY INFORMATION: copies total. One copy will include the use an alternative approach if it satisfies information you claim to be confidential I. Background the requirements of the applicable with a heading or cover note that states statutes and regulations. Increasingly, patients seek to play an ‘‘THIS DOCUMENT CONTAINS active role in their own healthcare. FDA III. Electronic Access CONFIDENTIAL INFORMATION.’’ The believes that manufacturers providing Agency will review this copy, including the claimed confidential information, in patients with accurate, useable Persons interested in obtaining a copy its consideration of comments. The information about their healthcare of the draft guidance may do so by second copy, which will have the (including the medical products they downloading an electronic copy from claimed confidential information use and patient-specific information the Internet. A search capability for all redacted/blacked out, will be available these products generate) will improve Center for Devices and Radiological for public viewing and posted on http:// healthcare by empowering patients to Health guidance documents is available www.regulations.gov. Submit both participate fully with their healthcare at http://www.fda.gov/MedicalDevices/ copies to the Division of Dockets providers in making sound medical DeviceRegulationandGuidance/ Management. If you do not wish your decisions. For purposes of this GuidanceDocuments/default.htm. name and contact information to be guidance, patient-specific information is Guidance documents are also available made publicly available, you can defined as any information unique to an at http://www.regulations.gov. Persons provide this information on the cover individual patient or unique to that unable to download an electronic copy sheet and not in the body of your patient’s treatment or diagnosis that of ‘‘Dissemination of Patient-Specific comments and you must identify this may be recorded, stored, processed, retrieved, and/or derived from a medical Information from Devices by Device information as ‘‘confidential.’’ Any Manufacturers’’ may send an email information marked as ‘‘confidential’’ device. This information may include, but is not limited to, recorded patient request to CDRH-Guidance@fda.hhs.gov will not be disclosed except in to receive an electronic copy of the accordance with 21 CFR 10.20 and other data, device usage/output statistics, healthcare provider inputs, incidence of document. Please use the document applicable disclosure law. For more alarms, and/or records of device number 1500067 to identify the information about FDA’s posting of comments to public dockets, see 80 FR malfunctions or failures. guidance you are requesting. 56469, September 18, 2015, or access FDA developed this draft guidance to IV. Paperwork Reduction Act of 1995 the information at: http://www.fda.gov/ convey FDA’s policy regarding the regulatoryinformation/dockets/ dissemination of patient-specific This guidance refers to previously default.htm. information recorded, stored, processed, approved collections of information Docket: For access to the docket to retrieved, and/or derived from a medical found in FDA regulations and guidance. read background documents or the device and provided by the These collections of information are electronic and written/paper comments manufacturer to the patient who is subject to review by the Office of received, go to http:// either treated or diagnosed with that Management and Budget (OMB) under www.regulations.gov and insert the specific device. This draft guidance the Paperwork Reduction Act of 1995 docket number, found in brackets in the document also outlines considerations (44 U.S.C. 3501–3520). The collections heading of this document, into the for the form in which this information of information in 21 CFR parts 801 and ‘‘Search’’ box and follow the prompts is communicated to help to ensure 809, regarding device labeling, are and/or go to the Division of Dockets clarity of content and appropriate approved under OMB control number Management, 5630 Fishers Lane, Rm. context. Manufacturers may share patient- 0910–0485. 1061, Rockville, MD 20852. asabaliauskas on DSK3SPTVN1PROD with NOTICES An electronic copy of the guidance specific information (recorded, stored, Dated: June 6, 2016. document is available for download processed, retrieved, and/or derived Leslie Kux, from the Internet. See the from a medical device, consistent with Associate Commissioner for Policy. SUPPLEMENTARY INFORMATION section for the intended use of that medical device) [FR Doc. 2016–13787 Filed 6–9–16; 8:45 am] information on electronic access to the with patients either on their own BILLING CODE 4164–01–P guidance. Submit written requests for a initiative or at the patient’s request, single hard copy of the draft guidance without obtaining additional premarket document entitled ‘‘Dissemination of review before doing so. Any labeling, as VerDate Sep<11>2014 19:02 Jun 09, 2016 Jkt 238001 PO 00000 Frm 00039 Fmt 4703 Sfmt 9990 E:\FR\FM\10JNN1.SGM 10JNN1


Document Created: 2018-02-08 07:35:51
Document Modified: 2018-02-08 07:35:51
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of availability.
DatesAlthough 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 August 9, 2016.
ContactSugato De, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 5435, Silver Spring, MD 20993-0002, 301-796-6270, [email protected]
FR Citation81 FR 37603 
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