80 FR 17047 - Electronic Study Data Submission; Data Standards; Recommending the Use of the World Health Organization Drug Dictionary
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 61 (March 31, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 61 (March 31, 2015)
| Page Range | 17047-17047 | |
| FR Document | 2015-07269 |
[Federal Register Volume 80, Number 61 (Tuesday, March 31, 2015)] [Notices] [Page 17047] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-07269] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-0815] Electronic Study Data Submission; Data Standards; Recommending the Use of the World Health Organization Drug Dictionary AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing support for the World Health Organization (WHO) Drug Dictionary (available at http://www.who-umc.org/), which is maintained and updated by the Uppsala Monitoring Centre. FDA is encouraging sponsors and applicants to use WHO Drug Dictionary codes in investigational study data provided in regulatory submissions to the Center for Drug Evaluation and Research and to the Center for Biologics Evaluation and Research. The WHO Drug Dictionary contains unique codes for identifying drug names and evaluating medicinal product information, including active ingredients and therapeutic uses. Typically, WHO Drug Dictionary is used to code concomitant medications used by subjects during the course of a clinical trial. WHO Drug Dictionary will be listed in the FDA Data Standards Catalog posted to FDA's Study Data Standards Resources Web site 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 May 5, 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, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002 or the Office of Communication, Outreach, and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., 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, [email protected]; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 71, Rm. 7301, Silver Spring, MD 20993, [email protected]. SUPPLEMENTARY INFORMATION: I. Background The use of a common dictionary to code concomitant medications is an important component of study data standardization. Generally, controlled terminology standards specify the key concepts that are represented as definitions, preferred terms, synonyms, codes, and code system. The analysis of study data is greatly facilitated by the use of controlled terms for clinical or scientific concepts that have standard, predefined meanings and representations. WHO Drug Dictionary contains unique codes as drug names and corresponding medicinal product information, including active ingredients and the Anatomical Therapeutic Chemical (ATC) classification system for the therapeutic uses. Typically, sponsors and applicants use WHO Drug Dictionary to code and analyze concomitant medications taken by subjects during the course of clinical trials. Although use of WHO Drug Dictionary codes are not required at this time, FDA now supports and encourages the use of WHO Drug Dictionary coded concomitant medications used in clinical trials. For purposes of this notice, ``supported'' means the receiving Center has established processes and technology to support receiving, processing, reviewing, and archiving files in the specified standard. FDA is now encouraging sponsors and applicants to provide WHO Drug Dictionary codes for concomitant medication data in investigational studies provided in regulatory submissions (e.g., investigational new drug applications, new drug applications, abbreviated new drug applications, and biologics license applications). The codes should include the drug product trade name where available, the active ingredient(s) and the ATC class. 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: March 23, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-07269 Filed 3-30-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 61 / Tuesday, March 31, 2015 / Notices 17047
Name of Committee: Center for Scientific Standards Resources Web site at analyze concomitant medications taken
Review Special Emphasis Panel; Member http://www.fda.gov/forindustry/ by subjects during the course of clinical
Conflict: Hypertension, Thrombosis, Vascular datastandards/studydatastandards/ trials.
Inflammation and Dysfunction. Although use of WHO Drug
default.htm
Date: April 23–24, 2015.
Time: 8:00 a.m. to 5:00 p.m. DATES: Although you can comment on
Dictionary codes are not required at this
Agenda: To review and evaluate grant this notice at any time, to ensure that time, FDA now supports and encourages
applications. the Agency considers your comments the use of WHO Drug Dictionary coded
Place:National Institutes of Health, 6701 submit either electronic or written concomitant medications used in
Rockledge Drive, Bethesda, MD 20892,
comments by May 5, 2015. clinical trials. For purposes of this
(Virtual Meeting). notice, ‘‘supported’’ means the receiving
Contact Person: Natalia Komissarova, ADDRESSES: Submit written requests for
Center has established processes and
Ph.D., Scientific Review Officer, Center for single copies of the documents to the
technology to support receiving,
Scientific Review, National Institutes of Division of Drug Information, Center for
Health, 6701 Rockledge Drive, Room 5207,
processing, reviewing, and archiving
Drug Evaluation and Research, Food
MSC 7846, Bethesda, MD 20892, 301–435– files in the specified standard.
and Drug Administration, 10001 New FDA is now encouraging sponsors and
1206, komissar@mail.nih.gov. Hampshire Ave., Hillandale Building,
(Catalogue of Federal Domestic Assistance applicants to provide WHO Drug
4th Floor, Silver Spring, MD 20993– Dictionary codes for concomitant
Program Nos. 93.306, Comparative Medicine; 0002 or the Office of Communication,
93.333, Clinical Research, 93.306, 93.333, medication data in investigational
93.337, 93.393–93.396, 93.837–93.844,
Outreach, and Development, Center for studies provided in regulatory
93.846–93.878, 93.892, 93.893, National Biologics Evaluation and Research, submissions (e.g., investigational new
Institutes of Health, HHS). Food and Drug Administration, 10903 drug applications, new drug
New Hampshire Ave., Bldg. 71, Rm. applications, abbreviated new drug
Dated: March 25, 2015.
3128, Silver Spring, MD 20993–0002. applications, and biologics license
David Clary, Send one self-addressed adhesive label
Program Analyst, Office of Federal Advisory applications). The codes should include
to assist that office in processing your
Committee Policy. the drug product trade name where
requests.
[FR Doc. 2015–07256 Filed 3–30–15; 8:45 am] Submit electronic comments to http:// available, the active ingredient(s) and
BILLING CODE 4140–01–P www.regulations.gov. Submit written the ATC class.
comments to the Division of Dockets II. Comments
Management (HFA–305), Food and Drug Interested persons may submit either
DEPARTMENT OF HEALTH AND Administration, 5630 Fishers Lane, Rm.
HUMAN SERVICES electronic comments to http://
1061, Rockville, MD 20852. www.regulations.gov or written
FOR FURTHER INFORMATION CONTACT: Ron comments regarding this notice to the
Food and Drug Administration
Fitzmartin, Center for Drug Evaluation Division of Dockets Management (see
[Docket No. FDA–2015–N–0815] and Research, Food and Drug ADDRESSES). It is only necessary to send
Administration, 10903 New Hampshire one set of comments. Identify comments
Electronic Study Data Submission; Ave. Bldg. 51, rm. 1192, Silver Spring,
Data Standards; Recommending the with the docket number found in
MD 20993–002, brackets in the heading of this
Use of the World Health Organization ronald.fitzmartin@fda.hhs.gov; or
Drug Dictionary document. Received comments may be
Stephen Ripley, Center for Biologics seen in the Division of Dockets
AGENCY: Food and Drug Administration, Evaluation and Research, Food and Management between 9 a.m. and 4 p.m.,
HHS. Drug Administration, 10903 New Monday through Friday, and will be
ACTION: Notice. Hampshire Ave. Bldg. 71, Rm. 7301, posted to the docket at http://
Silver Spring, MD 20993, www.regulations.gov.
SUMMARY: The Food and Drug stephen.ripley@fda.hhs.gov.
Dated: March 23, 2015.
Administration (FDA or Agency) is SUPPLEMENTARY INFORMATION:
announcing support for the World Leslie Kux,
Health Organization (WHO) Drug I. Background Associate Commissioner for Policy.
Dictionary (available at http:// The use of a common dictionary to [FR Doc. 2015–07269 Filed 3–30–15; 8:45 am]
www.who-umc.org/), which is code concomitant medications is an BILLING CODE 4164–01–P
maintained and updated by the Uppsala important component of study data
Monitoring Centre. FDA is encouraging standardization. Generally, controlled
sponsors and applicants to use WHO terminology standards specify the key DEPARTMENT OF HEALTH AND
Drug Dictionary codes in investigational concepts that are represented as HUMAN SERVICES
study data provided in regulatory definitions, preferred terms, synonyms,
Food and Drug Administration
submissions to the Center for Drug codes, and code system. The analysis of
Evaluation and Research and to the study data is greatly facilitated by the [Docket No. FDA–2015–D–0839]
Center for Biologics Evaluation and use of controlled terms for clinical or
Research. The WHO Drug Dictionary scientific concepts that have standard, Target Animal Safety Data
contains unique codes for identifying predefined meanings and Presentation and Statistical Analysis;
drug names and evaluating medicinal representations. WHO Drug Dictionary Draft Guidance for Industry;
asabaliauskas on DSK5VPTVN1PROD with NOTICES
product information, including active contains unique codes as drug names Availability
ingredients and therapeutic uses. and corresponding medicinal product AGENCY: Food and Drug Administration,
Typically, WHO Drug Dictionary is used information, including active HHS.
to code concomitant medications used ingredients and the Anatomical ACTION: Notice.
by subjects during the course of a Therapeutic Chemical (ATC)
clinical trial. WHO Drug Dictionary will classification system for the therapeutic SUMMARY: The Food and Drug
be listed in the FDA Data Standards uses. Typically, sponsors and applicants Administration (FDA) is announcing the
Catalog posted to FDA’s Study Data use WHO Drug Dictionary to code and availability of a draft guidance for
VerDate Sep<11>2014 18:32 Mar 30, 2015 Jkt 235001 PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 E:\FR\FM\31MRN1.SGM 31MRN1](https://thefederalregister.org/doc/80_FR_17108/page/1.svg)
Document Created: 2015-12-18 11:48:13
Document Modified: 2015-12-18 11:48:13
| 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. | |
| 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 May 5, 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, [email protected]; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 71, Rm. 7301, Silver Spring, MD 20993, [email protected] | |
| FR Citation | 80 FR 17047 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR