80 FR 46010 - Promoting Semantic Interoperability of Laboratory Data; Public Workshop; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 148 (August 3, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 148 (August 3, 2015)
| Page Range | 46010-46012 | |
| FR Document | 2015-18910 |
[Federal Register Volume 80, Number 148 (Monday, August 3, 2015)] [Notices] [Pages 46010-46012] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-18910] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-2372] Promoting Semantic Interoperability of Laboratory Data; Public Workshop; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop; request for comments. ----------------------------------------------------------------------- The Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and the National Library of Medicine (NLM) of the National Institutes of Health are announcing the following public workshop entitled ``FDA/CDC/NLM Workshop on Promoting Semantic Interoperability of Laboratory Data.'' The purpose of this workshop is to receive and discuss input from stakeholders regarding proposed approaches to promoting the semantic interoperability of laboratory data between in vitro diagnostic devices and database systems, including laboratory information systems and electronic health records. Date and Time: The public workshop will be held on September 28, 2015, from 8 a.m. to 5 p.m. Location: The public workshop will be held at FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993. Entrance for the public meeting participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. Contact Person: Steven Gitterman, Food and Drug Administration, Center for Devices and Radiological Health, Bldg. 66, Rm. 5518, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-6694, FAX: 301-847-2512, email: [email protected]. Registration: Registration is free and available on a first-come, first-served basis. Persons interested in attending this public workshop must register online by 4 p.m. September 18, 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 permits, onsite registration on the day of the public workshop will be provided beginning at 7 a.m. (EDT). If you need special accommodations due to a disability, please contact Susan Monahan, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5231, Silver Spring, MD 20993-0002, 301-796-5661, email: [email protected] no later than 4 p.m. on September 14, 2015. To register for the public workshop, please visit FDA's Medical Devices News & Events--Workshops & 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 and affiliation, address, email, and telephone number. Those without Internet access should contact Susan Monahan to register. 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 [[Page 46011]] online by September 18, 2015, 4 p.m. 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 23, 2015. If you have never attended a Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, visit http://www.adobe.com/go/connectpro_overview. (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.) Requests for Oral Presentations: This public workshop includes a public comment session. During online registration you may indicate if you wish to present during a public comment session, and which topics you wish to address. FDA has included general topics in this document which will be addressed in greater detail in a subsequent discussion paper (see SUPPLEMENTARY INFORMATION). FDA will do its best to accommodate requests to make public comments. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and request time for a joint presentation, or submit requests for designated representatives to participate in the focused sessions. All requests to make oral presentations must be received by September 2, 2015. FDA will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin, and will select and notify participants by September 7, 2015. If selected for presentation, any presentation materials must be emailed to Michael Waters at [email protected] no later than September 18, 2015, 5 p.m. No commercial or promotional material will be permitted to be presented or distributed at the public workshop. Comments: FDA, CDC, and NLM are holding this public workshop to receive input from stakeholders and discuss proposed approaches to promoting the semantic interoperability of laboratory data between in vitro diagnostic devices and database systems, including electronic health records. 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 topics. The deadline for submitting comments related to this public workshop is 4 p.m. on October 26, 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. 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. It may be viewed at the Division of Dockets Management (see Comments). 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. (Select this public workshop from the posted events list). SUPPLEMENTARY INFORMATION: I. Background There is broad acknowledgement that interoperability between information providers and information consumers is essential for progress in health care. Semantic interoperability is the building block for permitting meaningful use of medical information across disparate systems; it is essential for supporting patient care, medical research, epidemiology, and numerous other patient health public health goals. Laboratory tests are a critical aspect of patient care that may influence between 70 to 80 percent of clinical decisions and represent an important target for achieving interoperability. Much of laboratory information is directly generated by medical devices and as such should be readily amenable to standardization that would enable semantic interoperability; however, significant challenges exist both in the adoption of standards by device manufacturers and implementation by clinical and public health laboratories. FDA, CDC, and NLM are in unique positions to encourage and promote the adoption of standards for laboratory data that can enable semantic interoperability through the public health mandate of the Department of Human and Health Services (HHS), the role of FDA in device regulation, the leadership role of CDC in laboratory science and support, and the pivotal role of NLM in the development, enhancement, and adoption of clinical vocabulary standards. The primary purpose of this workshop is to discuss and receive input from stakeholders regarding standards for the reporting of laboratory data and means to facilitate adoption by industry and laboratories. Specific models for semantic interoperability of laboratory data will be discussed, including the use of Logical Observation Identifiers Names and Codes (LOINC) for identifying laboratory tests, uniform Systematized Nomenclature of Medicine- Clinical Terms (SNOMED-CT) coding sets for describing results of qualitative test results and Unified Code for Units of Measure (UCUM) reporting of quantitative results. The use of other standards within interoperable laboratory result messages such as Unique Device Identifier (UDI) codes will also be addressed, as well as mechanisms for distributing device coding information such as Structured Product Labeling (SPL) or Electronically Exchanging Directory of Services (eDOS). Specifically, NLM, CDC, and FDA seek input from laboratorians, industry, government, academia, health care practitioners, and other stakeholders on these topics. This discussion is viewed as essential in expediting the adoption of standards to facilitate semantic interoperability of laboratory results. II. Topics for Discussion at the Public Workshop This public workshop will consist of brief presentations providing information to frame the goals of the workshop, and an interactive discussion via several panel sessions. The presentations will focus on proposed interoperability standards and mechanisms to promote adoption and implementation. Following the presentations there will be a moderated discussion where the participants and additional panelists will be asked to provide their individual perspectives. In advance of the meeting, FDA, CDC, and NLM will place a summary of the issues they believe need to be addressed for promoting semantic interoperability [[Page 46012]] on file in the public docket (docket number found in brackets in the heading of this document) and will post it at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. The deadline for submitting comments to this document for presentation at the public workshop is September 18, 2015, although comments related to this document can be made until September 28, 2015. The Agencies will use the input from this workshop and public comments to determine appropriate next steps to advance sematic interoperability of laboratory data. Dated: July 28, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-18910 Filed 7-31-15; 8:45 am] BILLING CODE 4164-01-P
![46010 Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices
email address indicated in the Food and Drug Administration. Date and Time: The public workshop
registration file, or via regular mail if Payments can be mailed to: Food and will be held on September 28, 2015,
email is not an option. The invoice will Drug Administration, P.O. Box 956733, from 8 a.m. to 5 p.m.
contain information regarding the St. Louis, MO 63195–6733. If a check is Location: The public workshop will
obligation incurred, the amount owed, sent by a courier that requests a street be held at FDA White Oak Campus,
and payment procedures. A facility will address, the courier can deliver the 10903 New Hampshire Ave., Building
not be deemed registered as an check to: U.S. Bank, Attn: Government 31 Conference Center, the Great Room
outsourcing facility until it has paid the Lockbox 956733, 1005 Convention (Rm. 1503), Silver Spring, MD 20993.
annual establishment fee under section Plaza, St. Louis, MO 63101. (Note: This Entrance for the public meeting
744K of the FD&C Act. Accordingly, it U.S. Bank address is for courier delivery participants (non-FDA employees) is
is important that facilities seeking to only; do not send mail to this address.) through Building 1 where routine
operate as registered outsourcing 3. If paying with a wire transfer: Use security check procedures will be
facilities pay all fees immediately upon the following account information when performed. For parking and security
receiving an invoice. If an entity does sending a wire transfer: New York information, please refer to http://
not pay the full invoiced amount within Federal Reserve Bank, U.S. Dept of www.fda.gov/AboutFDA/
15 calendar days after FDA issues the Treasury, TREAS NYC, 33 Liberty St., WorkingatFDA/BuildingsandFacilities/
invoice, FDA will consider the New York, NY 10045, Acct. No. WhiteOakCampusInformation/
submission of registration information 75060099, Routing No. 021030004, ucm241740.htm.
to have been withdrawn and adjust the SWIFT: FRNYUS33, Beneficiary: FDA, Contact Person: Steven Gitterman,
invoice to reflect that no fee is due. 8455 Colesville Rd., Silver Spring, MD Food and Drug Administration, Center
Outsourcing facilities that registered 20993. The originating financial for Devices and Radiological Health,
in FY 2015 and wish to maintain their institution may charge a wire transfer Bldg. 66, Rm. 5518, 10903 New
status as an outsourcing facility in FY fee. An outsourcing facility should ask Hampshire Ave., Silver Spring, MD
2016 must register during the annual its financial institution about the fee 20993–0002, 301–796–6694, FAX: 301–
registration period that lasts from and add it to the payment to ensure that 847–2512, email: steven.gitterman@
October 1, 2015, to December 31, 2015. the order is fully paid. The tax fda.hhs.gov.
Failure to register and complete Registration: Registration is free and
identification number of FDA is 53–
payment by December 31, 2015, will available on a first-come, first-served
0196965.
result in a loss of status as an basis. Persons interested in attending
outsourcing facility on January 1, 2016. Dated: July 28, 2015. this public workshop must register
Entities should submit their registration Leslie Kux, online by 4 p.m. September 18, 2015.
information no later than December 10, Associate Commissioner for Policy. Early registration is recommended
2015, to allow enough time for review [FR Doc. 2015–18916 Filed 7–31–15; 8:45 am] because facilities are limited and,
of the registration information, BILLING CODE 4164–01–P therefore, FDA may limit the number of
invoicing, and payment of fees before participants from each organization. If
the end of the registration period. time and space permits, onsite
DEPARTMENT OF HEALTH AND registration on the day of the public
B. Reinspection Fee HUMAN SERVICES workshop will be provided beginning at
FDA will issue invoices for each 7 a.m. (EDT).
reinspection after the conclusion of the Food and Drug Administration If you need special accommodations
reinspection, via email to the email due to a disability, please contact Susan
[Docket No. FDA–2015–N–2372]
address indicated in the registration file Monahan, Center for Devices and
or via regular mail if email is not an Promoting Semantic Interoperability of Radiological Health, Food and Drug
option. Invoices must be paid within 30 Laboratory Data; Public Workshop; Administration, 10903 New Hampshire
days. Request for Comments Ave., Bldg. 32, Rm. 5231, Silver Spring,
MD 20993–0002, 301–796–5661, email:
C. Fee Payment Procedures AGENCY: Food and Drug Administration, susan.monahan@fda.hhs.gov no later
1. The preferred payment method is HHS. than 4 p.m. on September 14, 2015.
online using electronic check ACTION: Notice of public workshop; To register for the public workshop,
(Automated Clearing House (ACH) also request for comments. please visit FDA’s Medical Devices
known as eCheck) or credit card News & Events—Workshops &
(Discover, VISA, MasterCard, American The Food and Drug Administration Conferences calendar at http://
Express). Secure electronic payments (FDA), the Centers for Disease Control www.fda.gov/MedicalDevices/
can be submitted using the User Fees and Prevention (CDC), and the National NewsEvents/WorkshopsConferences/
Payment Portal at https:// Library of Medicine (NLM) of the default.htm. (Select this public
userfees.fda.gov/pay. Once you search National Institutes of Health are workshop from the posted events list.)
for your invoice, click ‘‘Pay Now’’ to be announcing the following public Please provide complete contact
redirected to Pay.gov. Note that workshop entitled ‘‘FDA/CDC/NLM information for each attendee, including
electronic payment options are based on Workshop on Promoting Semantic name, title and affiliation, address,
the balance due. Payment by credit card Interoperability of Laboratory Data.’’ email, and telephone number. Those
is available for balances less than The purpose of this workshop is to without Internet access should contact
mstockstill on DSK4VPTVN1PROD with NOTICES
$50,000. If the balance exceeds this receive and discuss input from Susan Monahan to register. Registrants
amount, only the ACH option is stakeholders regarding proposed will receive confirmation after they have
available. Payments must be drawn on approaches to promoting the semantic been accepted. You will be notified if
U.S. bank accounts as well as U.S. credit interoperability of laboratory data you are on a waiting list.
cards. between in vitro diagnostic devices and Streaming Webcast of the Public
2. If paying with a paper check: database systems, including laboratory Workshop: This public workshop will
Checks must be in U.S. currency from information systems and electronic also be Webcast. Persons interested in
a U.S. bank and made payable to the health records. viewing the Webcast must register
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![46012 Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices
on file in the public docket (docket SUPPLEMENTARY INFORMATION: II. Revenue Amount for FY 2016
number found in brackets in the
I. Background A. Statutory Fee Revenue Amounts
heading of this document) and will post
it at http://www.fda.gov/ Section 741 of the FD&C Act (21 AGDUFA II, Title II of Public Law
MedicalDevices/NewsEvents/ U.S.C. 379j–21) establishes three 113–14, specifies that the aggregate
WorkshopsConferences/default.htm. different types of user fees: (1) Fees for revenue amount for FY 2016 for
The deadline for submitting comments abbreviated application fees is
certain types of abbreviated applications
to this document for presentation at the $1,857,000 and each of the other two
for generic new animal drugs; (2) annual
public workshop is September 18, 2015, generic new animal drug user fee
fees for certain generic new animal drug
although comments related to this categories, annual product fees and
products; and (3) annual fees for certain
document can be made until September annual sponsor fees, is $2,786,000 each
sponsors of abbreviated applications for
28, 2015. (see 21 U.S.C. 379j–21(b)).
generic new animal drugs and/or
The Agencies will use the input from
investigational submissions for generic B. Inflation Adjustment to Fee Revenue
this workshop and public comments to
new animal drugs (21 U.S.C. 379j– Amount
determine appropriate next steps to
advance sematic interoperability of 21(a)). When certain conditions are met, The amounts established in AGDUFA
laboratory data. FDA will waive or reduce fees for II for each year for FY 2014 through FY
generic new animal drugs intended 2018 include an inflation adjustment;
Dated: July 28, 2015. solely to provide for a minor use or therefore, no further inflation
Leslie Kux, minor species indication (21 U.S.C. adjustment is required.
Associate Commissioner for Policy. 379j–21(d)).
[FR Doc. 2015–18910 Filed 7–31–15; 8:45 am] C. Workload Adjustment Fee Revenue
For FY 2014 through FY 2018, the Amount
BILLING CODE 4164–01–P
FD&C Act establishes aggregate yearly
base revenue amounts for each of these For each FY beginning after FY 2014,
fee categories. Base revenue amounts AGDUFA provides that statutory fee
DEPARTMENT OF HEALTH AND revenue amounts shall be further
HUMAN SERVICES established for fiscal years after FY 2014
may be adjusted for workload. The adjusted to reflect changes in review
Food and Drug Administration target revenue amounts for each fee workload. (See 21 U.S.C. 379j–21(c)(2).)
category for FY 2016, after the FDA calculated the average number of
[Docket No. FDA–2015–N–0007] each of the four types of applications
adjustment for workload, are as follows:
For application fees the target revenue and submissions specified in the
Animal Generic Drug User Fee Rates workload adjustment provision
and Payment Procedures for Fiscal amount is $2,426,000; for product fees
the target revenue amount is $3,639,000; (abbreviated applications for generic
Year 2016 new animal drugs, manufacturing
and for sponsor fees the target revenue
AGENCY: Food and Drug Administration, amount is $3,639,000. supplemental abbreviated applications
HHS. for generic new animal drugs,
For FY 2016, the generic new animal investigational generic new animal drug
ACTION: Notice.
drug user fee rates are: $233,300 for study submissions, and investigational
SUMMARY: The Food and Drug each abbreviated application for a generic new animal drug protocol
Administration (FDA) is announcing the generic new animal drug other than submissions) received over the 5-year
fee rates and payment procedures for those subject to the criteria in section period that ended on September 30,
fiscal year (FY) 2016 generic new 512(d)(4) of the FD&C Act (21 U.S.C. 2013 (the base years), and the average
animal drug user fees. The Federal 360b(d)(4)); $116,650 for each number of each of these types of
Food, Drug, and Cosmetic Act (the abbreviated application for a generic applications and submissions over the
FD&C Act), as amended by the Animal new animal drug subject to the criteria most recent 5-year period that ended on
Generic Drug User Fee Amendments of in section 512(d)(4); $8,705 for each June 30, 2015.
2013 (AGDUFA II), authorizes FDA to generic new animal drug product; The results of these calculations are
collect user fees for certain abbreviated $83,800 for each generic new animal presented in the first two columns in
applications for generic new animal drug sponsor paying 100 percent of the table 1. Column 3 reflects the percent
drugs, for certain generic new animal sponsor fee; $62,850 for each generic change in workload over the two 5-year
drug products, and for certain sponsors new animal drug sponsor paying 75 periods. Column 4 shows the weighting
of such abbreviated applications for percent of the sponsor fee; and $41,900 factor for each type of application,
generic new animal drugs and/or for each generic new animal drug reflecting how much of the total FDA
investigational submissions for generic sponsor paying 50 percent of the generic new animal drug review
new animal drugs. This notice sponsor fee. FDA will issue invoices for workload was accounted for by each
establishes the fee rates for FY 2016. FY 2016 product and sponsor fees by type of application or submission in the
FOR FURTHER INFORMATION CONTACT: Visit December 31, 2015. These fees will be table during the most recent 5 years.
FDA’s Web site at http://www.fda.gov/ due by January 31, 2016. The Column 5 is the weighted percent
ForIndustry/UserFees/AnimalGeneric application fee rates are effective for all change in each category of workload
DrugUserFeeActAGDUFA/default.htm, abbreviated applications for a generic and was derived by multiplying the
or contact Lisa Kable, Center for new animal drug submitted on or after weighting factor in each line in column
mstockstill on DSK4VPTVN1PROD with NOTICES
Veterinary Medicine (HFV–10), Food October 1, 2015, and will remain in 4 by the percent change from the base
and Drug Administration, 7519 Standish effect through September 30, 2016. years in column 3. At the bottom right
Pl., Rockville, MD 20855, 240–402– Applications will not be accepted for of table 1, the sum of the values in
6888. For general questions, you may review until FDA has received full column 5 is calculated, reflecting a total
also email the Center for Veterinary payment of related application fees and change in workload of 30.6305 percent
Medicine (CVM) at cvmagdufa@ any other fees owed under the Animal for FY 2016. This is the workload
fda.hhs.gov. Generic Drug User Fee program. adjuster for FY 2016.
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Document Created: 2018-02-23 10:51:16
Document Modified: 2018-02-23 10:51:16
| 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 46010 |
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