80 FR 27690 - Electronic Study Data Submission; Data Standards; Support for the Logical Observation Identifiers Names and Codes
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 93 (May 14, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 93 (May 14, 2015)
| Page Range | 27690-27691 | |
| FR Document | 2015-11596 |
[Federal Register Volume 80, Number 93 (Thursday, May 14, 2015)] [Notices] [Pages 27690-27691] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-11596] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-1349] Electronic Study Data Submission; Data Standards; Support for the Logical Observation Identifiers Names and Codes AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is encouraging sponsors and applicants to provide Logical Observation Identifiers Names and Codes (LOINC) codes (available at http://loinc.org/) for clinical laboratory test results in investigational study data provided in regulatory submissions submitted to the Center for Drug Evaluation and Research and to the Center for Biologics Evaluation and Research. LOINC code is defined as electronic messages for laboratory test results and clinical observations. The decision to adopt LOINC for lab test results is part of a larger FDA effort to align the use of data standards for clinical research with ongoing nationwide health information technology initiatives. FDA invites public comment on appropriate steps the Agency could take to promote the use and utility of LOINC-coded clinical data submitted to the Agency. The LOINC common terminology will be listed in the FDA Data Standards Catalog that is posted to FDA's Study Data Standards Resources Web page at http://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm. DATES: Although you can comment on this notice at any time, to ensure that the Agency considers your comments submit either electronic or written comments by June 29, 2015. ADDRESSES: Submit written requests for single copies of the documents to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002 or the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Ron Fitzmartin, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1192, Silver Spring, MD 20993-002, 301- 796-5333, ronald.fitzmartin@fda.hhs.gov, or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-402-7911. SUPPLEMENTARY INFORMATION: I. Background LOINC is a clinical terminology housed by the Regenstrief Institute, a nonprofit medical research organization associated with Indiana University (available at http://www.regenstrief.org/). LOINC was initiated in 1994 as a response to the demand for electronic movement of clinical data from laboratories that produce the data to consumers of clinical data. LOINC codes are universal identifiers for laboratory and other clinical observations that enable semantically interoperable clinical data exchange. The purpose of LOINC is to facilitate the exchange and pooling of clinical data for clinical care, outcomes management, and research. The laboratory portion of the LOINC database contains the categories of chemistry, hematology, serology, microbiology (including parasitology and virology), toxicology, and more. The clinical portion of the LOINC database includes entries for vital signs, hemodynamics, intake/output, EKG, obstetric ultrasound, cardiac echo, urologic imaging, gastroendoscopic procedures, and selected survey instruments. FDA is now encouraging sponsors and applicants to provide LOINC codes for laboratory test data in investigational studies provided in regulatory submissions (e.g., investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs)) when those LOINC codes are available (e.g., from the clinical laboratory that performed the test). FDA supports LOINC-coded laboratory test results because: (1) LOINC is widely used among clinical laboratories, (2) LOINC-coded lab data make the information easier to understand and analyze, and (3) the currently supported exchange standard for laboratory test results in clinical trials, the Study Data Tabulation Model (available at http://www.cdisc.org/sdtm) already supports the exchange of LOINC codes. FDA's decision to adopt LOINC for lab test results is part of a larger FDA effort to align the use of data standards for clinical research with ongoing nationwide health information technology initiatives. FDA recognizes that there are additional steps the Agency could take to promote the use and utility of LOINC-coded clinical data submitted to the Agency. FDA invites public comment on what those additional steps should be, along with a suggested sequence and timing of those steps. For example, the Agency recognizes that the high level of granularity inherent in LOINC has [[Page 27691]] presented coding challenges and that these challenges have led to the creation of subsets of LOINC to help facilitate coding.Should FDA identify a LOINC subset for its use case? If yes, should FDA create its own subset or leverage existing subsets? Which LOINC subsets should FDA consider? What steps can FDA take to minimize the burden to sponsors and applicants in adopting LOINC within their organizations to support regulatory submissions? II. Comments Interested persons may submit either electronic comments to http://www.regulations.gov or written comments regarding this notice to the Division of Dockets Management (see ADDRESSES). 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. Dated: May 6, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-11596 Filed 5-13-15; 8:45 am] BILLING CODE 4164-01-P
![27690 Federal Register / Vol. 80, No. 93 / Thursday, May 14, 2015 / Notices
pharmaceuticals and related products. Logical Observation Identifiers Names I. Background
The goal of the conference is to ensure and Codes (LOINC) codes (available at LOINC is a clinical terminology
widespread opportunities for attendees http://loinc.org/) for clinical laboratory housed by the Regenstrief Institute, a
to learn about important and critical test results in investigational study data nonprofit medical research organization
issues that intersect with provided in regulatory submissions associated with Indiana University
pharmaceutical manufacturing quality submitted to the Center for Drug (available at http://www.regenstrief.org/).
and regulatory topics that impact Evaluation and Research and to the LOINC was initiated in 1994 as a
manufacturers, suppliers, and regulatory Center for Biologics Evaluation and response to the demand for electronic
health authorities. Research. LOINC code is defined as movement of clinical data from
electronic messages for laboratory test laboratories that produce the data to
II. Registration results and clinical observations. The consumers of clinical data. LOINC codes
There is a registration fee to attend decision to adopt LOINC for lab test
are universal identifiers for laboratory
this meeting. The registration fee is results is part of a larger FDA effort to
and other clinical observations that
charged to help defray the costs of align the use of data standards for
enable semantically interoperable
conference sessions and presentations, clinical research with ongoing
clinical data exchange. The purpose of
facilities, materials, and food. Seats are nationwide health information
LOINC is to facilitate the exchange and
limited, and registration will be on a technology initiatives. FDA invites
pooling of clinical data for clinical care,
first-come, first-served basis. public comment on appropriate steps
To register, please complete outcomes management, and research.
the Agency could take to promote the
registration online at http:// The laboratory portion of the LOINC
use and utility of LOINC-coded clinical
www.ispe.org/2015-quality- database contains the categories of
data submitted to the Agency. The
manufacturing-conference/fees-and- chemistry, hematology, serology,
LOINC common terminology will be
registration. (FDA has verified the Web microbiology (including parasitology
listed in the FDA Data Standards
address, but FDA is not responsible for and virology), toxicology, and more. The
Catalog that is posted to FDA’s Study
subsequent changes to the Web site after Data Standards Resources Web page at clinical portion of the LOINC database
this document publishes in the Federal includes entries for vital signs,
http://www.fda.gov/forindustry/
Register.) The costs of registration for datastandards/studydatastandards/ hemodynamics, intake/output, EKG,
the different categories of attendees are default.htm. obstetric ultrasound, cardiac echo,
as follows: urologic imaging, gastroendoscopic
DATES: Although you can comment on procedures, and selected survey
this notice at any time, to ensure that instruments.
Category Cost
the Agency considers your comments FDA is now encouraging sponsors and
ISPE Members ............................. $2,095 submit either electronic or written applicants to provide LOINC codes for
Nonmembers ................................ 2,475 comments by June 29, 2015. laboratory test data in investigational
Government .................................. 700 ADDRESSES: Submit written requests for studies provided in regulatory
single copies of the documents to the submissions (e.g., investigational new
III. Accommodations Division of Drug Information, Center for drug applications (INDs), new drug
Attendees are responsible for their Drug Evaluation and Research, Food applications (NDAs), abbreviated new
own hotel accommodations. Attendees and Drug Administration, 10903 New drug applications (ANDAs), biologics
making reservations at The Mayflower Hampshire Ave., Bldg. 51, Rm. 2201, license applications (BLAs)) when those
Renaissance, Washington DC, may Silver Spring, MD 20993–0002 or the LOINC codes are available (e.g., from
check for the availability of a reduced Office of Communication, Outreach and the clinical laboratory that performed
rate by mentioning ISPE when making Development, Center for Biologics the test). FDA supports LOINC-coded
their reservation. Evaluation and Research (CBER), Food laboratory test results because: (1)
and Drug Administration, 10903 New LOINC is widely used among clinical
Dated: May 8, 2015. Hampshire Avenue, Bldg. 71, Rm. 3128, laboratories, (2) LOINC-coded lab data
Leslie Kux, Silver Spring, MD 20993–0002. Send make the information easier to
Associate Commissioner for Policy. one self-addressed adhesive label to understand and analyze, and (3) the
[FR Doc. 2015–11620 Filed 5–13–15; 8:45 am] assist that office in processing your currently supported exchange standard
BILLING CODE 4164–01–P requests. for laboratory test results in clinical
Submit electronic comments to trials, the Study Data Tabulation Model
http://www.regulations.gov. Submit (available at http://www.cdisc.org/sdtm)
DEPARTMENT OF HEALTH AND written comments to the Division of already supports the exchange of LOINC
HUMAN SERVICES Dockets Management (HFA–305), Food codes. FDA’s decision to adopt LOINC
and Drug Administration, 5630 Fishers for lab test results is part of a larger FDA
Food and Drug Administration Lane, Rm. 1061, Rockville, MD 20852. effort to align the use of data standards
[Docket No. FDA–2015–N–1349] FOR FURTHER INFORMATION CONTACT: Ron for clinical research with ongoing
Fitzmartin, Center for Drug Evaluation nationwide health information
Electronic Study Data Submission; and Research, Food and Drug technology initiatives.
Data Standards; Support for the Administration, 10903 New Hampshire FDA recognizes that there are
Logical Observation Identifiers Names Ave., Bldg. 51, Rm. 1192, Silver Spring, additional steps the Agency could take
and Codes MD 20993–002, 301–796–5333, to promote the use and utility of LOINC-
tkelley on DSK3SPTVN1PROD with NOTICES
AGENCY: Food and Drug Administration, ronald.fitzmartin@fda.hhs.gov, or coded clinical data submitted to the
HHS. Stephen Ripley, Center for Biologics Agency. FDA invites public comment
ACTION: Notice; request for comments.
Evaluation and Research, Food and on what those additional steps should
Drug Administration, Bldg. 71, Rm. be, along with a suggested sequence and
SUMMARY: The Food and Drug 7301, Silver Spring, MD 20993, 240– timing of those steps. For example, the
Administration (FDA) is encouraging 402–7911. Agency recognizes that the high level of
sponsors and applicants to provide SUPPLEMENTARY INFORMATION: granularity inherent in LOINC has
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![Federal Register / Vol. 80, No. 93 / Thursday, May 14, 2015 / Notices 27691
presented coding challenges and that and Drug Administration, 8455 202–395–7285, or emailed to oira_
these challenges have led to the creation Colesville Rd., COLE–14526, Silver submission@omb.eop.gov. All
of subsets of LOINC to help facilitate Spring, MD 20993–0002, PRAStaff@ comments should be identified with the
coding. fda.hhs.gov. OMB control number 0910-New and
• Should FDA identify a LOINC title ‘‘Survey of Pharmacists and
SUPPLEMENTARY INFORMATION: On
subset for its use case? Patients; Variations in the Physical
• If yes, should FDA create its own February 18, 2015, the Agency
submitted a proposed collection of Characteristics of Generic Drug Pills and
subset or leverage existing subsets? Patients’ Perceptions.’’ Also include the
• Which LOINC subsets should FDA information entitled, ‘‘Dispute
Resolution Procedures for Science FDA docket number found in brackets
consider? in the heading of this document.
• What steps can FDA take to Based Decisions on Products Regulated
by the Center for Veterinary Medicine’’ FOR FURTHER INFORMATION CONTACT: FDA
minimize the burden to sponsors and
to OMB for review and clearance under PRA Staff, Office of Operations, Food
applicants in adopting LOINC within
44 U.S.C. 3507. An Agency may not and Drug Administration, 8455
their organizations to support regulatory
conduct or sponsor, and a person is not Colesville Rd., COLE–14526, Silver
submissions?
required to respond to, a collection of Spring, MD 20993–0002, PRAStaff@
II. Comments information unless it displays a fda.hhs.gov.
Interested persons may submit either currently valid OMB control number. SUPPLEMENTARY INFORMATION: In
electronic comments to http:// OMB has now approved the information compliance with 44 U.S.C. 3507, FDA
www.regulations.gov or written collection and has assigned OMB has submitted the following proposed
comments regarding this notice to the control number 0910–0566. The collection of information to OMB for
Division of Dockets Management (see approval expires on April 30, 2018. A review and clearance.
ADDRESSES). It is only necessary to send copy of the supporting statement for this
one set of comments. Identify comments Survey of Pharmacists and Patients;
information collection is available on
with the docket number found in Variations in the Physical
the Internet at http://www.reginfo.gov/
brackets in the heading of this Characteristics of Generic Drug Pills
public/do/PRAMain.
document. Received comments may be and Patients’ Perceptions (OMB Control
Dated: May 6, 2015. No. 0910—NEW)
seen in the Division of Dockets Leslie Kux,
Management between 9 a.m. and 4 p.m., Generic drugs make up approximately
Associate Commissioner for Policy. 85 percent of all human prescription
Monday through Friday, and will be
[FR Doc. 2015–11608 Filed 5–13–15; 8:45 am] drugs prescribed in the United States.
posted to the docket at http://
www.regulations.gov. BILLING CODE 4164–01–P While generic drugs are required to be
Dated: May 6, 2015. pharmaceutically equivalent and
bioequivalent to their brand-name
Leslie Kux, DEPARTMENT OF HEALTH AND counterparts, generics made by different
Associate Commissioner for Policy. HUMAN SERVICES manufacturers may differ substantially
[FR Doc. 2015–11596 Filed 5–13–15; 8:45 am] from their brand-name therapeutic
BILLING CODE 4164–01–P Food and Drug Administration
equivalents and from each other in their
[Docket No. FDA–2014–N–1491] physical appearance (e.g., color, shape,
or size of pills). When pharmacists
DEPARTMENT OF HEALTH AND Agency Information Collection switch generic drug suppliers, patients
HUMAN SERVICES Activities; Submission for Office of refilling their generic prescriptions may
Management and Budget Review; therefore experience changes in their
Food and Drug Administration
Comment Request; Survey of drugs’ appearances. These changes may
[Docket No. FDA–2011–N–0509] Pharmacists and Patients; Variations result in patient confusion and concerns
in the Physical Characteristics of about the safety and effectiveness of the
Agency Information Collection Generic Drug Pills and Patients’ generic drug products. Studies indicate
Activities; Announcement of Office of Perceptions that patients are more likely to stop
Management and Budget Approval;
AGENCY: Food and Drug Administration, taking their generic medications when
Dispute Resolution Procedures for
HHS. they experience a change in their drugs’
Science Based Decisions on Products
physical appearances, leading to
Regulated by the Center for Veterinary ACTION: Notice. harmful clinical and public health
Medicine
SUMMARY: The Food and Drug consequences as well as increased
AGENCY: Food and Drug Administration, Administration (FDA) is announcing health care costs from avoidable
HHS. that a proposed collection of morbidity and mortality.
ACTION: Notice. information has been submitted to the To provide additional information
Office of Management and Budget that may help guide regulatory policy or
SUMMARY: The Food and Drug pharmacy business practices, we intend
(OMB) for review and clearance under
Administration (FDA) is announcing to conduct surveys of pharmacists and
the Paperwork Reduction Act of 1995.
that a collection of information entitled, patients about their perceptions about
‘‘Dispute Resolution Procedures for DATES: Fax written comments on the
and experiences with generic drug
Science Based Decisions on Products collection of information by June 15, product pill appearance change. These
2015.
tkelley on DSK3SPTVN1PROD with NOTICES
Regulated by the Center for Veterinary surveys are intended to further our
Medicine’’ has been approved by the ADDRESSES: To ensure that comments on understanding of the relationship
Office of Management and Budget the information collection are received, between changes in pill appearance and
(OMB) under the Paperwork Reduction OMB recommends that written non-adherence to prescribed therapeutic
Act of 1995. comments be faxed to the Office of regimens. The surveys may enable us to
FOR FURTHER INFORMATION CONTACT: FDA Information and Regulatory Affairs, investigate factors that may explain the
PRA Staff, Office of Operations, Food OMB, Attn: FDA Desk Officer, FAX: association between changes in pill
VerDate Sep<11>2014 17:59 May 13, 2015 Jkt 235001 PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 E:\FR\FM\14MYN1.SGM 14MYN1](https://thefederalregister.org/doc/80_FR_27783/page/2.svg)
Document Created: 2015-12-15 15:32:46
Document Modified: 2015-12-15 15:32:46
| 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; request for comments. | |
| Dates | Although you can comment on this notice at any time, to ensure that the Agency considers your comments submit either electronic or written comments by June 29, 2015. | |
| Contact | Ron Fitzmartin, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1192, Silver Spring, MD 20993-002, 301- 796-5333, [email protected], or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-402-7911. | |
| FR Citation | 80 FR 27690 |
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