Electronic Study Data Submission; Data Standards; Support for the Logical Observation Identifiers Names and Codes, 27690-27691 [2015-11596]

Download as PDF 27690 Federal Register / Vol. 80, No. 93 / Thursday, May 14, 2015 / Notices Logical Observation Identifiers Names and Codes (LOINC) codes (available at https://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 II. Registration results and clinical observations. The There is a registration fee to attend decision to adopt LOINC for lab test this meeting. The registration fee is results is part of a larger FDA effort to charged to help defray the costs of align the use of data standards for conference sessions and presentations, clinical research with ongoing facilities, materials, and food. Seats are nationwide health information limited, and registration will be on a technology initiatives. FDA invites first-come, first-served basis. public comment on appropriate steps To register, please complete the Agency could take to promote the registration online at https:// use and utility of LOINC-coded clinical www.ispe.org/2015-qualitydata submitted to the Agency. The manufacturing-conference/fees-andLOINC common terminology will be registration. (FDA has verified the Web listed in the FDA Data Standards address, but FDA is not responsible for Catalog that is posted to FDA’s Study subsequent changes to the Web site after Data Standards Resources Web page at this document publishes in the Federal https://www.fda.gov/forindustry/ Register.) The costs of registration for datastandards/studydatastandards/ the different categories of attendees are default.htm. as follows: DATES: Although you can comment on this notice at any time, to ensure that Category Cost the Agency considers your comments ISPE Members ............................. $2,095 submit either electronic or written Nonmembers ................................ 2,475 comments by June 29, 2015. Government .................................. 700 ADDRESSES: Submit written requests for single copies of the documents to the III. Accommodations Division of Drug Information, Center for Drug Evaluation and Research, Food Attendees are responsible for their and Drug Administration, 10903 New own hotel accommodations. Attendees Hampshire Ave., Bldg. 51, Rm. 2201, making reservations at The Mayflower Silver Spring, MD 20993–0002 or the Renaissance, Washington DC, may Office of Communication, Outreach and check for the availability of a reduced Development, Center for Biologics rate by mentioning ISPE when making Evaluation and Research (CBER), Food their reservation. and Drug Administration, 10903 New Dated: May 8, 2015. Hampshire Avenue, Bldg. 71, Rm. 3128, Leslie Kux, Silver Spring, MD 20993–0002. Send Associate Commissioner for Policy. one self-addressed adhesive label to [FR Doc. 2015–11620 Filed 5–13–15; 8:45 am] assist that office in processing your requests. BILLING CODE 4164–01–P Submit electronic comments to https://www.regulations.gov. Submit DEPARTMENT OF HEALTH AND written comments to the Division of HUMAN SERVICES Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Food and Drug Administration Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Ron [Docket No. FDA–2015–N–1349] Fitzmartin, Center for Drug Evaluation Electronic Study Data Submission; and Research, Food and Drug Data Standards; Support for the Administration, 10903 New Hampshire Logical Observation Identifiers Names Ave., Bldg. 51, Rm. 1192, Silver Spring, and Codes MD 20993–002, 301–796–5333, AGENCY: Food and Drug Administration, ronald.fitzmartin@fda.hhs.gov, or Stephen Ripley, Center for Biologics HHS. Evaluation and Research, Food and ACTION: Notice; request for comments. Drug Administration, Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240– SUMMARY: The Food and Drug 402–7911. Administration (FDA) is encouraging sponsors and applicants to provide SUPPLEMENTARY INFORMATION: tkelley on DSK3SPTVN1PROD with NOTICES pharmaceuticals and related products. The goal of the conference is to ensure widespread opportunities for attendees to learn about important and critical issues that intersect with pharmaceutical manufacturing quality and regulatory topics that impact manufacturers, suppliers, and regulatory health authorities. VerDate Sep<11>2014 17:59 May 13, 2015 Jkt 235001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 I. Background LOINC is a clinical terminology housed by the Regenstrief Institute, a nonprofit medical research organization associated with Indiana University (available at https://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 https://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 LOINCcoded 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 E:\FR\FM\14MYN1.SGM 14MYN1 Federal Register / Vol. 80, No. 93 / Thursday, May 14, 2015 / Notices 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 https:// 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 https:// www.regulations.gov. Dated: May 6, 2015. Leslie Kux, Associate Commissioner for Policy. and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. On February 18, 2015, the Agency submitted a proposed collection of information entitled, ‘‘Dispute Resolution Procedures for Science Based Decisions on Products Regulated by the Center for Veterinary Medicine’’ to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0566. The approval expires on April 30, 2018. A copy of the supporting statement for this information collection is available on the Internet at https://www.reginfo.gov/ public/do/PRAMain. SUPPLEMENTARY INFORMATION: Dated: May 6, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–11608 Filed 5–13–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2015–11596 Filed 5–13–15; 8:45 am] Food and Drug Administration BILLING CODE 4164–01–P [Docket No. FDA–2014–N–1491] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–N–0509] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Dispute Resolution Procedures for Science Based Decisions on Products Regulated by the Center for Veterinary Medicine AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled, ‘‘Dispute Resolution Procedures for Science Based Decisions on Products Regulated by the Center for Veterinary Medicine’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food tkelley on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:59 May 13, 2015 Jkt 235001 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Survey of Pharmacists and Patients; Variations in the Physical Characteristics of Generic Drug Pills and Patients’ Perceptions AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by June 15, 2015. SUMMARY: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: ADDRESSES: PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 27691 202–395–7285, or emailed to oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910-New and title ‘‘Survey of Pharmacists and Patients; Variations in the Physical Characteristics of Generic Drug Pills and Patients’ Perceptions.’’ Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Survey of Pharmacists and Patients; Variations in the Physical Characteristics of Generic Drug Pills and Patients’ Perceptions (OMB Control No. 0910—NEW) Generic drugs make up approximately 85 percent of all human prescription drugs prescribed in the United States. While generic drugs are required to be pharmaceutically equivalent and bioequivalent to their brand-name counterparts, generics made by different manufacturers may differ substantially from their brand-name therapeutic equivalents and from each other in their physical appearance (e.g., color, shape, or size of pills). When pharmacists switch generic drug suppliers, patients refilling their generic prescriptions may therefore experience changes in their drugs’ appearances. These changes may result in patient confusion and concerns about the safety and effectiveness of the generic drug products. Studies indicate that patients are more likely to stop taking their generic medications when they experience a change in their drugs’ physical appearances, leading to harmful clinical and public health consequences as well as increased health care costs from avoidable morbidity and mortality. To provide additional information that may help guide regulatory policy or pharmacy business practices, we intend to conduct surveys of pharmacists and patients about their perceptions about and experiences with generic drug product pill appearance change. These surveys are intended to further our understanding of the relationship between changes in pill appearance and non-adherence to prescribed therapeutic regimens. The surveys may enable us to investigate factors that may explain the association between changes in pill E:\FR\FM\14MYN1.SGM 14MYN1

Agencies

[Federal Register Volume 80, Number 93 (Thursday, May 14, 2015)]
[Notices]
[Pages 27690-27691]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-11596]

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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 https://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 https://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 https://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 https://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 https://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 https://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 https://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

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