82_FR_49029 82 FR 48827 - Extension of the Timetable Requirement To Submit Study Data in Logical Observation Identifiers Names and Codes

82 FR 48827 - Extension of the Timetable Requirement To Submit Study Data in Logical Observation Identifiers Names and Codes

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 202 (October 20, 2017)

Page Range48827-48828
FR Document2017-22768

The Food and Drug Administration (FDA or the Agency) is announcing the extension of the deadline to provide Logical Observation Identifiers Names and Codes (LOINC) 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. FDA has determined, in response to industry comments and internal review, that it is appropriate to extend the date required to submit LOINC codes in new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs), and for certain investigational new drugs (INDs). LOINC codes will be required in NDAs, ANDAs, and BLAs for studies that start after March 15, 2020 (March 15, 2021, for certain INDs).

Federal Register, Volume 82 Issue 202 (Friday, October 20, 2017) 
[Federal Register Volume 82, Number 202 (Friday, October 20, 2017)]
[Notices]
[Pages 48827-48828]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-22768]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-1349]


Extension of the Timetable Requirement To Submit Study Data in 
Logical Observation Identifiers Names and Codes

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
announcing the extension of the deadline to provide Logical Observation 
Identifiers Names and Codes (LOINC)

[[Page 48828]]

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. FDA has determined, in response to industry comments and 
internal review, that it is appropriate to extend the date required to 
submit LOINC codes in new drug applications (NDAs), abbreviated new 
drug applications (ANDAs), and biologics license applications (BLAs), 
and for certain investigational new drugs (INDs). LOINC codes will be 
required in NDAs, ANDAs, and BLAs for studies that start after March 
15, 2020 (March 15, 2021, for certain INDs).

ADDRESSES: You may submit either electronic or written comments at any 
time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. 
Comments submitted electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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.''
    Instructions: All submissions received must include the Docket No. 
FDA-2015-N-1349 for ``Extension of the Timetable Requirement to Submit 
Study Data in Logical Observation Identifiers Names and Codes.'' 
Received comments will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. 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: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 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. 1115, Silver Spring, MD 20993-0002, 301-
796-5333, [email protected]; or Stephen Ripley, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 71, Rm. 7268, Silver Spring, MD 20993-0002, 
240-402-7911, [email protected].

SUPPLEMENTARY INFORMATION: On May 14, 2015, FDA announced in the 
Federal Register (80 FR 27690) its adoption of LOINC for lab test 
results. 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 
(available at https://loinc.org/). 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. The FDA Data Standards Catalog was 
updated to indicate FDA support for LOINC and a requirement date of 
March 15, 2018, for NDAs, ANDAs, and BLAs, and March 15, 2019, for 
certain INDs (see https://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm). FDA has determined, in response to 
industry comments and internal review, that it is appropriate to extend 
the date required to submit LOINC codes. LOINC codes will be required 
in NDAs, ANDAs, and BLAs for studies that start after March 15, 2020 
(March 15, 2021, for certain INDs). Although use of LOINC codes are not 
required at this time, FDA continues to support and encourages the use 
of LOINC codes for clinical laboratory test results used in 
investigational study data.

    Dated: October 16, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-22768 Filed 10-19-17; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 202 / Friday, October 20, 2017 / Notices 48827 fdsys/pkg/FR-2015-09-18/pdf/2015- on July 14, 2017 (82 FR 32556). This TABLE 2—REVISED DRAFT PRODUCT- 23389.pdf. notice announces draft product-specific SPECIFIC GUIDANCES FOR DRUG Docket: For access to the docket to guidances, either new or revised, that PRODUCTS—Continued read background documents or the are posted on FDA’s Web site. electronic and written/paper comments Lisdexamfetamine dimesylate. II. Drug Products for Which New Draft Mesalamine. received, go to https:// Product-Specific Guidances Are Mycophenolate mofetil. www.regulations.gov and insert the Available Ofloxacin. docket number, found in brackets in the Olopatadine hydrochloride (multiple Ref- heading of this document, into the FDA is announcing the availability of erence Listed Drugs). ‘‘Search’’ box and follow the prompts new draft product-specific guidances for Ropinirole hydrochloride. and/or go to the Dockets Management industry for drug products containing Sucralfate. Staff, 5630 Fishers Lane, Rm. 1061, the following active ingredients: Tadalafil. Rockville, MD 20852. You may submit comments on any TABLE 1—NEW DRAFT PRODUCT-SPE- For a complete history of previously guidance at any time (see 21 CFR CIFIC GUIDANCES FOR DRUG PROD- published Federal Register notices 10.115(g)(5)). UCTS related to product-specific guidances, go Submit written requests for single to https://www.regulations.gov and copies of the draft guidances to the Azelastine hydrochloride. enter Docket No. FDA–2007–D–0369. Division of Drug Information, Center for Azithromycin. These draft guidances are being Drug Evaluation and Research, Food Barium sulfate. issued consistent with FDA’s good and Drug Administration, 10001 New Betamethasone dipropionate. guidance practices regulation (21 CFR Budesonide. 10.115). These draft guidances, when Hampshire Ave., Hillandale Building, Canagliflozin; Metformin hydrochloride. 4th Floor, Silver Spring, MD 20993– finalized, will represent the current Dantrolene sodium. 0002. Send one self-addressed adhesive Dapsone. thinking of FDA on, among other things, label to assist that office in processing Deflazacort (multiple Reference Listed the product-specific design of BE your requests. See the SUPPLEMENTARY Drugs). studies to support ANDAs. They do not INFORMATION section for electronic Docosanol. establish any rights for any person and access to the draft guidance documents. Empagliflozin; Metformin hydrochloride. are not binding on FDA or the public. Epinephrine. You can use an alternative approach if FOR FURTHER INFORMATION CONTACT: Erythromycin. Xiaoqiu Tang, Center for Drug it satisfies the requirements of the Everolimus. Evaluation and Research (HFD–600), Fluorometholone. applicable statutes and regulations. This Food and Drug Administration, 10903 Hydrocortisone acetate. guidance is not subject to Executive New Hampshire Ave., Bldg. 75, Rm. Ivermectin. Order 12866. 4730, Silver Spring, MD 20993–0002, Levorphanol tartrate. IV. Electronic Access 301–796–5850. Lisdexamfetamine dimesylate. Mometasone furoate. Persons with access to the internet SUPPLEMENTARY INFORMATION: Nitisinone. may obtain the draft guidances at either Olaparib. https://www.fda.gov/Drugs/Guidance I. Background Osimertinib mesylate. ComplianceRegulatoryInformation/ In the Federal Register of June 11, Permethrin. Guidances/default.htm or https:// 2010 (75 FR 33311), FDA announced the Pirfenidone. Telotristat etiprate. www.regulations.gov. availability of a guidance for industry entitled ‘‘Bioequivalence Terbutaline sulfate. Dated: October 16, 2017. Recommendations for Specific Anna K. Abram, Products’’ that explained the process III. Drug Products for Which Revised Deputy Commissioner for Policy, Planning, that would be used to make product- Draft Product-Specific Guidances Are Legislation, and Analysis. specific guidances available to the Available [FR Doc. 2017–22736 Filed 10–19–17; 8:45 am] public on FDA’s Web site at https:// FDA is announcing the availability of BILLING CODE 4164–01–P www.fda.gov/Drugs/Guidance revised draft product-specific guidances ComplianceRegulatoryInformation/ for industry for drug products Guidances/default.htm. containing the following active DEPARTMENT OF HEALTH AND As described in that guidance, FDA ingredients: HUMAN SERVICES adopted this process as a means to Food and Drug Administration develop and disseminate product- TABLE 2—REVISED DRAFT PRODUCT- specific guidances and provide a SPECIFIC GUIDANCES FOR DRUG [Docket No. FDA–2015–N–1349] meaningful opportunity for the public to PRODUCTS consider and comment on those Extension of the Timetable guidances. Under that process, draft Requirement To Submit Study Data in Brimonidine tartrate (multiple Reference List- guidances are posted on FDA’s Web site ed Drugs). Logical Observation Identifiers Names and announced periodically in the Bromfenac sodium. and Codes Federal Register. The public is Ciprofloxacin hydrochloride. AGENCY: Food and Drug Administration, encouraged to submit comments on Cobicistat; Elvitegravir; Emtricitabine; srobinson on DSKBC5CHB2PROD with NOTICES HHS. those recommendations within 60 days Tenofovir alafenamide fumarate. Dapsone. ACTION: Notice. of their announcement in the Federal Diclofenac sodium. Register. FDA considers any comments Emtricitabine; Rilpivirine hydrochloride; SUMMARY: The Food and Drug received and either publishes final Tenofovir alafenamide fumarate. Administration (FDA or the Agency) is guidances or publishes revised draft Emtricitabine; Tenofovir alafenamide fuma- announcing the extension of the guidances for comment. Guidances were rate. deadline to provide Logical Observation last announced in the Federal Register Esomeprazole magnesium. Identifiers Names and Codes (LOINC) VerDate Sep<11>2014 16:22 Oct 19, 2017 Jkt 244001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 E:\FR\FM\20OCN1.SGM 20OCN1

48828 Federal Register / Vol. 82, No. 202 / Friday, October 20, 2017 / Notices for clinical laboratory test results in Instructions: All submissions received Evaluation and Research, Food and investigational study data provided in must include the Docket No. FDA– Drug Administration, 10903 New regulatory submissions submitted to the 2015–N–1349 for ‘‘Extension of the Hampshire Ave., Bldg. 71, Rm. 7268, Center for Drug Evaluation and Research Timetable Requirement to Submit Study Silver Spring, MD 20993–0002, 240– and to the Center for Biologics Data in Logical Observation Identifiers 402–7911, stephen.ripley@fda.hhs.gov. Evaluation and Research. FDA has Names and Codes.’’ Received comments SUPPLEMENTARY INFORMATION: On May determined, in response to industry will be placed in the docket and, except 14, 2015, FDA announced in the comments and internal review, that it is for those submitted as ‘‘Confidential Federal Register (80 FR 27690) its appropriate to extend the date required Submissions,’’ publicly viewable at adoption of LOINC for lab test results. to submit LOINC codes in new drug https://www.regulations.gov or at the FDA supports LOINC-coded laboratory applications (NDAs), abbreviated new Dockets Management Staff between test results because: (1) LOINC is widely drug applications (ANDAs), and 9 a.m. and 4 p.m., Monday through used among clinical laboratories; (2) biologics license applications (BLAs), Friday. LOINC-coded lab data make the and for certain investigational new • Confidential Submissions—To information easier to understand and drugs (INDs). LOINC codes will be submit a comment with confidential analyze; and (3) the currently supported required in NDAs, ANDAs, and BLAs information that you do not wish to be exchange standard for laboratory test for studies that start after March 15, made publicly available, submit your results in clinical trials, the Study Data 2020 (March 15, 2021, for certain INDs). comments only as a written/paper Tabulation Model (available at http:// ADDRESSES: You may submit either submission. You should submit two www.cdisc.org/sdtm), already supports electronic or written comments at any copies total. One copy will include the the exchange of LOINC codes (available time as follows: information you claim to be confidential at https://loinc.org/). FDA’s decision to Electronic Submissions with a heading or cover note that states adopt LOINC for lab test results is part ‘‘THIS DOCUMENT CONTAINS of a larger FDA effort to align the use of Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The data standards for clinical research with following way: Agency will review this copy, including • Federal eRulemaking Portal: ongoing nationwide health information the claimed confidential information, in technology initiatives. The FDA Data https://www.regulations.gov. Follow the its consideration of comments. The instructions for submitting comments. Standards Catalog was updated to second copy, which will have the indicate FDA support for LOINC and a Comments submitted electronically, claimed confidential information including attachments, to https:// requirement date of March 15, 2018, for redacted/blacked out, will be available NDAs, ANDAs, and BLAs, and March www.regulations.gov will be posted to for public viewing and posted on the docket unchanged. Because your 15, 2019, for certain INDs (see https:// https://www.regulations.gov. Submit www.fda.gov/forindustry/ comment will be made public, you are both copies to the Dockets Management solely responsible for ensuring that your datastandards/studydatastandards/ Staff. If you do not wish your name and default.htm). FDA has determined, in comment does not include any contact information to be made publicly confidential information that you or a response to industry comments and available, you can provide this internal review, that it is appropriate to third party may not wish to be posted, information on the cover sheet and not such as medical information, your or extend the date required to submit in the body of your comments and you LOINC codes. LOINC codes will be anyone else’s Social Security number, or must identify this information as confidential business information, such required in NDAs, ANDAs, and BLAs ‘‘confidential.’’ Any information marked for studies that start after March 15, as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed that if you include your name, contact 2020 (March 15, 2021, for certain INDs). except in accordance with 21 CFR 10.20 Although use of LOINC codes are not information, or other information that and other applicable disclosure law. For identifies you in the body of your required at this time, FDA continues to more information about FDA’s posting support and encourages the use of comments, that information will be of comments to public dockets, see 80 posted on https://www.regulations.gov. LOINC codes for clinical laboratory test FR 56469, September 18, 2015, or access results used in investigational study • If you want to submit a comment the information at: https://www.gpo.gov/ with confidential information that you data. fdsys/pkg/FR-2015-09-18/pdf/2015- do not wish to be made available to the 23389.pdf. Dated: October 16, 2017. public, submit the comment as a Docket: For access to the docket to Leslie Kux, written/paper submission and in the read background documents or the Associate Commissioner for Policy. manner detailed (see ‘‘Written/Paper electronic and written/paper comments [FR Doc. 2017–22768 Filed 10–19–17; 8:45 am] Submissions’’ and ‘‘Instructions’’). received, go to https:// BILLING CODE 4164–01–P Written/Paper Submissions www.regulations.gov and insert the Submit written/paper submissions as docket number, found in brackets in the heading of this document, into the DEPARTMENT OF HEALTH AND follows: HUMAN SERVICES • Mail/Hand delivery/Courier (for ‘‘Search’’ box and follow the prompts written/paper submissions): Dockets and/or go to the Dockets Management Food and Drug Administration Management Staff (HFA–305), Food and Staff, 5630 Fishers Lane, Rm. 1061, Drug Administration, 5630 Fishers Rockville, MD 20852. [Docket No. FDA–2017–D–6133] FOR FURTHER INFORMATION CONTACT: Ron srobinson on DSKBC5CHB2PROD with NOTICES Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments Fitzmartin, Center for Drug Evaluation Application of the ‘‘Solely Engaged’’ submitted to the Dockets Management and Research, Food and Drug Exemptions in Parts 117 and 507; Draft Staff, FDA will post your comment, as Administration, 10903 New Hampshire Guidance for Industry; Availability well as any attachments, except for Ave., Bldg. 51, Rm. 1115, Silver Spring, AGENCY: Food and Drug Administration, information submitted, marked and MD 20993–0002, 301–796–5333, HHS. identified, as confidential, if submitted cderdatastandards@fda.hhs.gov; or ACTION: Notification of availability. as detailed in ‘‘Instructions.’’ Stephen Ripley, Center for Biologics VerDate Sep<11>2014 16:22 Oct 19, 2017 Jkt 244001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\FR\FM\20OCN1.SGM 20OCN1


Document Created: 2017-10-20 00:06:29
Document Modified: 2017-10-20 00:06:29
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.
ContactRon Fitzmartin, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1115, Silver Spring, MD 20993-0002, 301- 796-5333, [email protected]; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7268, Silver Spring, MD 20993-0002, 240-402-7911, [email protected]
FR Citation82 FR 48827 
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