80 FR 43093 - Medical Device Patient Labeling; Request for Comments; Public Workshop
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 139 (July 21, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 139 (July 21, 2015)
| Page Range | 43093-43095 | |
| FR Document | 2015-17800 |
[Federal Register Volume 80, Number 139 (Tuesday, July 21, 2015)] [Notices] [Pages 43093-43095] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-17800] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2000-D-0067] Medical Device Patient Labeling; Request for Comments; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration is announcing the following public workshop entitled ``Medical Device Patient Labeling''. The purpose of the public workshop is to discuss issues associated with the development and use of medical device [[Page 43094]] patient labeling including content, testing, use, access, human factors, emerging media formats, and promotion and advertising. The Center for Devices and Radiological Health (CDRH) is seeking input into these topics from patients and advocacy groups, academic and professional organizations, industry, standards organizations, and governmental Agencies. Ideas generated during this workshop will help facilitate development or revision of guidances and/or standards for medical device patient labeling. Date and Time: The workshop will be held on September 29, 2015, from 8 a.m. to 5 p.m. and September 30, 2015, from 8 a.m. to 5 p.m. Location: The public workshop will be held at FDA's White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503A), Silver Spring, MD 20993-0002. Entrance for the public workshop participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please visit the following Web site: http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm Contact Person: Antoinette (Tosia) Hazlett, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5424, Silver Spring, MD 20993-0002, 301-796-6119, [email protected] gov. Registration: Registration is free and available on a first-come, first-served basis. Persons interested in attending the ``Medical Device Patient Labeling'' public workshop must register online by 4 p.m. on September 21, 2015. Early registration is recommended because facilities are limited and, therefore, FDA may limit the number of participants from each organization. If time and space permit, onsite registration on the days of the public workshop will be provided beginning at 7 a.m. If you need special accommodations due to a disability, please contact Susan Monahan at least 7 days in advance of the meeting. To register for the public workshop, please visit CDRH's Workshops and Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list.) Please provide complete contact information for each attendee, including name, title, affiliation, email, and telephone number. Those without Internet access should contact Susan Monahan to register (see Contact Person). Registrants will receive confirmation after they have been accepted. You will be notified if you are on a waiting list. Streaming Webcast of the Public Workshop: This public workshop will also be Webcast. Persons interested in viewing the Webcast must register online by 4 p.m. on September 21, 2015. Early registration is recommended because Webcast connections are limited. Organizations are requested to register all participants, but to view using one connection per location. Webcast participants will be sent technical system requirements after registration and will be sent connection access information after September 25, 2015. If you have never attended a Connect Pro event before, test your connections at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. (FDA has verified the Web site addresses in this document, but FDA is not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.) Comments: FDA is holding this public workshop to obtain stakeholder input on medical device patient labeling. In order to permit the widest possible opportunity to obtain public comment, FDA is soliciting either electronic or written comments on all aspects of the public workshop. The deadline for submitting comments regarding this public workshop is October 30, 2015. Regardless of attendance at the public workshop, interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville MD 20852. It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. In addition, when responding to specific topics as outlined in ``Topics for Discussion'', please identify the topic you are addressing. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov. Transcripts: Please be advised that as soon as a transcript is available, it will be accessible at: http://www.regulations.gov. A transcript will also be available in either hardcopy or on CD-ROM, after submission of a Freedom of Information request. Written requests are to be sent to the Division of Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857. A link to the transcripts will also be available approximately 45 days after the public workshop on the Internet at: http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. SUPPLEMENTARY INFORMATION: I. Background The CDRH Guidance on Medical Device Patient Labeling (available at http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm070782.htm) serves to assist manufacturers in their development of patient labeling and to assist Center reviewers in their review and evaluation of the manufacturers' labeling. Medical device patient labeling includes any medical device information that is intended for a lay audience. It is intended to help assure that the device is used safely and effectively. This labeling may pertain to therapeutic, restorative, diagnostic, or cosmetic devices. Medical device patient labeling is supplied in many formats, for example: As patient brochures, patient leaflets, user manuals, videos or audio recording, and through physical or online media. This labeling is intended to be supplied to or available to patients or their lay caregivers for their use with or without accompanying professional counseling. While some patients receive labeling from their healthcare practitioners or device suppliers, others receive it in the packaging of over-the-counter devices. CDRH is collecting public comment to use in updating the Medical Device Patient Labeling Guidance. FDA is committed to supporting the development and availability of patient labeling which supports the safe and effective use of medical devices by patients. To inform FDA in their efforts, they are seeking input on the topics identified in section II. II. Topics for Discussion FDA seeks to address and receive comments on the following topics: A. Current Medical Device Patient Labeling (1) The current use and practice trends of medical device patient labeling development and use. For example: When is medical device patient labeling used? How much medical device patient labeling exists? How much modification and revision of existing medical device patient labeling [[Page 43095]] occurs, and under what circumstances? What is the role of voluntary consensus standards in developing medical device patient labeling? (2) What risks or adverse outcomes have been reported in association with the use of medical device patient labeling? What communication barriers have been encountered, and how can they be mitigated? (3) Is there any part of the medical device patient labeling development process that presents a barrier to receiving approval or clearance from CDRH? If so, please provide examples of the specific issues, how frequently this occurs, and suggestions which constructively address these barriers. (4) What are the best ways to foster efficient networking with patients and advocacy groups, academic and professional organizations, industry, standards organizations, and government Agencies to address medical device patient labeling needs? B. Medical Device Patient Labeling Needs Assessment (1) Describe the parameters that should be used in determining priority areas of development of medical device patient labeling, including both therapeutic and diagnostic devices. (2) What are best practices for conducting a needs assessment of medical device patient labeling? C. Advancing Development (1) What could advance the development and use of medical device patient labeling? (2) How should patient labeling be considered in the development stages of all medical device labeling? (3) What resources (e.g., registries, industry, or patient advocacy groups,) could be tapped to advance the development of medical device patient labeling? (4) What are potential changes to guidances and regulations, or advances in current science that may help develop and enhance medical device patient labeling to address the needs of medical device manufacturers, device suppliers, and device users? Dated: July 15, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-17800 Filed 7-20-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 139 / Tuesday, July 21, 2015 / Notices 43093
Through the pilot test, we will Description: This is a financial report annually report on the methodology
determine the response rate that can be submitted following the end of each used to calculate adoption savings due
achieved using this approach. If it is fiscal quarter by each State or Tribe with to the application of differing title IV–
deemed necessary, a prenotification an approved title IV–E plan E Adoption Assistance eligibility
letter, additional mailout reminders and administering any of three title IV–E criteria for children designated as an
a telephone non-response step can be entitlement grant programs—Foster ‘‘applicable child’’ along with an
added to the protocol to achieve desired Care, Adoption Assistance or accounting of the amount of and the
response rate. Form Number: CMS– Guardianship Assistance. expenditure of any such savings.
10393 (OMB Control number: 0938– The purpose of this form is to enable To accommodate this change in the
1177); Frequency: Once; Affected each State or Tribe to meet its statutory law, we have added additional data
Public: Individuals or households; and regulatory requirement to report entry lines in part 4 of Form CB–496,
Number of Respondents: 16,010; program expenditures made in the ‘‘Annual Adoption Savings Calculation
Number of Responses: 16,010; Total preceding fiscal quarter and to estimate and Accounting Report’’ which will be
Annual Hours: 4,002. (For policy program expenditures to be made in the submitted annually by grantees.
questions regarding this collection, upcoming fiscal quarter. This form also
In addition, the same law adds
contact Coles Mercier at 410–786–2112.) allows States and Tribes to report the
additional requirements that title IV–E
actual and estimated average monthly
Dated: July 16, 2015. grantees develop and implement
number of children assisted in each of
William N. Parham, III, policies and procedures to identify,
the three IV–E entitlement grant
Director, Paperwork Reduction Staff, Office document, and determine appropriate
programs in the preceding and
of Strategic Operations and Regulatory services for any child or youth in the
upcoming fiscal quarters, respectively.
Affairs. The Administration for Children and placement, care or supervision of the
[FR Doc. 2015–17824 Filed 7–20–15; 8:45 am] Families provides Federal funding at the title IV–E agency who is at-risk of
BILLING CODE 4120–01–P rate of 50 percent for nearly all becoming a sex trafficking victim or
allowable and legitimate administrative who is determined as a sex trafficking
costs of these programs and at other victim.
DEPARTMENT OF HEALTH AND funding rates for other specific To accommodate this change in the
HUMAN SERVICES categories of costs as detailed in Federal law we have added additional reporting
statute and regulations. The information lines and prior quarter reporting odes
Administration for Children and collected in this report is used by this for expenditure reporting and child
Families agency to calculate quarterly Federal counts and in parts 1 and 2 of Form CB–
grant awards and to enable oversight of 496.
Submission for OMB Review; the financial management of the Respondents: States (including Puerto
Comment Request programs. Legislation enacted in 2014 Rico and the District of Columbia) and
through Public Law 113–183, the Tribes* with approved title IV–E plans.
Title: Form CB–496, ‘‘Title IV–E ‘‘Preventing Sex Trafficking and (*An estimated 15 Tribes have or will
Programs Quarterly Financial Report’’ Strengthening Families Act’’ added a have approved title IV–E plans within
OMB No.: 0970–0205 requirement that title IV–E grantees the next 3-year period.)
ANNUAL BURDEN ESTIMATES
Number of Average
Number of Total burden
Instrument responses per burden hours
respondents hours
respondent per response
Form CB–496: Title IV–E Programs Quarterly Financial Report .................... 67 4 21 5,628
Estimated Total Annual Burden publication. Written comments and DEPARTMENT OF HEALTH AND
Hours: 5,628. recommendations for the proposed HUMAN SERVICES
Additional Information: information collection should be sent
Copies of the proposed collection may directly to the following: Office of Food and Drug Administration
be obtained by writing to the Management and Budget, Paperwork [Docket No. FDA–2000–D–0067]
Administration for Children and Reduction Project, Email:
Families, Office of Planning, Research OIRA_SUBMISSION@OMB.EOP.GOV, Medical Device Patient Labeling;
and Evaluation, 370 L’Enfant Attn: Desk Officer for the Request for Comments; Public
Promenade SW., Washington, DC 20447, Administration for Children and Workshop
Attn: ACF Reports Clearance Officer. All Families. AGENCY: Food and Drug Administration,
requests should be identified by the title HHS.
of the information collection. Email Robert Sargis,
address: infocollection@acf.hhs.gov. Reports Clearance Officer. ACTION: Notice of public workshop;
asabaliauskas on DSK5VPTVN1PROD with NOTICES
request for comments.
OMB Comment: [FR Doc. 2015–17793 Filed 7–20–15; 8:45 am]
OMB is required to make a decision BILLING CODE 4184–01–P SUMMARY: The Food and Drug
concerning the collection of information Administration is announcing the
between 30 and 60 days after following public workshop entitled
publication of this document in the ‘‘Medical Device Patient Labeling’’. The
Federal Register. Therefore, a comment purpose of the public workshop is to
is best assured of having its full effect discuss issues associated with the
if OMB receives it within 30 days of development and use of medical device
VerDate Sep<11>2014 17:58 Jul 20, 2015 Jkt 235001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\FR\FM\21JYN1.SGM 21JYN1](https://thefederalregister.org/doc/80_FR_43232/page/1.svg)
![Federal Register / Vol. 80, No. 139 / Tuesday, July 21, 2015 / Notices 43095
occurs, and under what circumstances? DEPARTMENT OF HEALTH AND SUPPLEMENTARY INFORMATION:
What is the role of voluntary consensus HUMAN SERVICES I. Funding Opportunity Description
standards in developing medical device
patient labeling? Food and Drug Administration Funding Opportunity Number: RFA–
FD–15–035
(2) What risks or adverse outcomes [Docket No. FDA–2014–N–0411] Catalog of Federal Domestic
have been reported in association with Assistance Number: 93.103
the use of medical device patient Cooperative Agreement for Research,
Education, and Outreach in Support of A. Background
labeling? What communication barriers
the Food and Drug Administration FDA has supported the NCFST under
have been encountered, and how can
Food Safety Modernization Act seven previously awarded cooperative
they be mitigated?
AGENCY: Food and Drug Administration, agreements (53 FR 15736, 56 FR 46189,
(3) Is there any part of the medical
HHS. 59 FR 24703, 64 FR 39512, 69 FR 25405,
device patient labeling development
ACTION: Notice. 74 FR 26408, and 79 FR 23360). NCFST
process that presents a barrier to was established by IIT to bring together
receiving approval or clearance from SUMMARY: The Food and Drug the food safety and technology expertise
CDRH? If so, please provide examples of Administration (FDA) is announcing the of academia, industry, and FDA for the
the specific issues, how frequently this availability of grant funds for a purpose of supporting research and
occurs, and suggestions which cooperative agreement to support the outreach efforts related to the safety of
constructively address these barriers. FDA Food Safety Modernization Act foods based on a common goal of
(4) What are the best ways to foster (FSMA) implementation efforts by the enhancing the safety of the food supply
efficient networking with patients and Illinois Institute of Technology’s (IIT) for U.S. consumers. NCFST has been
advocacy groups, academic and National Center for Food Safety and successful in developing research
professional organizations, industry, Technology (NCFST). The estimated programs such as those related to low-
amount of support in fiscal year (FY) moisture foods, and outreach programs
standards organizations, and
2015 will be for up to $5 million (direct such as those related to sprout safety;
government Agencies to address
plus indirect costs), with the possibility these successes were achieved as a
medical device patient labeling needs? of 2 additional years of support for up result of NCFST partnering with
B. Medical Device Patient Labeling to $7 million each year, subject to the industry, academia, and FDA.
Needs Assessment availability of funds. This award will NCFST is structured so that
improve public health by continued representatives of participating
(1) Describe the parameters that support of an applied research, organizations play a role in establishing
should be used in determining priority education, and outreach program related policy and administrative procedures,
areas of development of medical device to the science behind and as well as identifying long- and short-
patient labeling, including both implementation of preventive controls, term research, outreach, and training
therapeutic and diagnostic devices. and on training and technical needs. With this organizational
assistance. structure, NCFST is able to build
(2) What are best practices for
conducting a needs assessment of DATES: Important dates are as follows: cooperative food safety programs on a
medical device patient labeling? 1. The application due date is August foundation of knowledge about current
14, 2015. industrial trends in food processing and
C. Advancing Development 2. The anticipated start date is packaging technologies, regulatory
September 1, 2015. perspectives from public health
(1) What could advance the 3. The opening date is August 1, 2015. organizations, and fundamental
development and use of medical device 4. The expiration date is August 31, scientific expertise from academia. This
patient labeling? 2015. award will improve public health by
(2) How should patient labeling be ADDRESSES: Submit the electronic continued support of an applied
considered in the development stages of application to: http://www.grants.gov. research, education, and outreach
all medical device labeling? For more information, see section III of program related to the science behind
the SUPPLEMENTARY INFORMATION section and implementation of preventive
(3) What resources (e.g., registries, of this notice.
industry, or patient advocacy groups,) controls associated with manufacturing,
FOR FURTHER INFORMATION CONTACT: processing, packing, and holding of
could be tapped to advance the Wanda Honeyblue, Food and Drug human and animal food, and on training
development of medical device patient Administration, Center for Food Safety and technical assistance.
labeling? and Applied Nutrition (CFSAN), 5100
(4) What are potential changes to Paint Branch Pkwy. (HFS–002), Rm. B. Program Objectives
guidances and regulations, or advances 4D–034, College Park, MD 20740, 301– With an increasingly diverse domestic
in current science that may help 796–3500, email: wanda.honeyblue@ and global food supply, FDA continues
develop and enhance medical device fda.hhs.gov; or Martin Bernard, Division to face complex food safety issues
patient labeling to address the needs of of State Acquisitions, Agreements and associated with the foods that it
medical device manufacturers, device Grants (DSAAG) (HFA–500), Food and regulates. Some of these complex issues
Drug Administration, 5630 Fishers can be effectively addressed by further
asabaliauskas on DSK5VPTVN1PROD with NOTICES
suppliers, and device users?
Lane, Rockville, MD 20857, 240–402– strengthening the available science-
Dated: July 15, 2015. 7564, email: Martin.Bernard@ based programs established through
Leslie Kux, fda.hhs.gov. NCFST/Institute for Food Safety and
Associate Commissioner for Policy. For more information on this funding Health (IFSH). FDA also believes that
[FR Doc. 2015–17800 Filed 7–20–15; 8:45 am] opportunity announcement (FOA) and innovative research and outreach
BILLING CODE 4164–01–P
to obtain detailed requirements, please programs such as those established at
refer to the full FOA located at http:// NCFST/IFSH can further support the
www.grants.gov/. development of proactive approaches to
VerDate Sep<11>2014 17:58 Jul 20, 2015 Jkt 235001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\FR\FM\21JYN1.SGM 21JYN1](https://thefederalregister.org/doc/80_FR_43232/page/3.svg)
Document Created: 2018-02-23 09:23:02
Document Modified: 2018-02-23 09:23:02
| 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 of public workshop; request for comments. | |
| FR Citation | 80 FR 43093 |
2024 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR