Study Data Technical Conformance Guide and Data Standards Catalog; Availability, 1508-1509 [2015-00206]
Download as PDF
1508
Federal Register / Vol. 80, No. 7 / Monday, January 12, 2015 / Notices
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On
September 30, 2014, the Agency
submitted a proposed collection of
information entitled ‘‘Reporting and
Recordkeeping Requirements for Human
Food and Cosmetics Manufactured
From, Processed With, or Otherwise
Containing, Material From Cattle’’ 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 0910–0623. The
approval expires on November 30, 2017.
A copy of the supporting statement for
this information collection is available
on the Internet at https://
www.reginfo.gov/public/do/PRAMain.
Dated: January 6, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–00204 Filed 1–9–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–0092]
Study Data Technical Conformance
Guide and Data Standards Catalog;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a Study Data Technical
Conformance Guide, Version 2.0
(Guide), and an update to the Data
Standards Catalog (Catalog). The Guide
supplements the final guidance for
industry entitled ‘‘Providing Regulatory
Submissions in Electronic Format—
Standardized Study Data’’ (eStudy Data
guidance) and provides specifications
and recommendations for, as well as
general considerations on, submitting
standardized study data using FDAsupported data standards specified in
the Catalog. The Guide is intended to
complement and promote interactions
between sponsors and FDA review
divisions.
DATES: Submit either electronic or
written comments on these documents
at any time.
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:35 Jan 09, 2015
Jkt 235001
Submit written requests for
a copy of the Study Data Technical
Conformance Guide and the Data
Standards Catalog 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. Send
one self-addressed adhesive label to
assist that office in processing your
requests.
Submit electronic comments on the
guidance 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 20993–0002, 301–796–5333,
ronald.fitzmartin@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
I. Background
FDA is announcing the availability of
Version 2.0 of the Guide and an update
to the Catalog. The Guide supplements
the final guidance for industry entitled
‘‘Providing Regulatory Submissions in
Electronic Format—Standardized Study
Data’’ (available at https://www.fda.gov/
Drugs/GuidanceComplianceRegulatory
Information/Guidances/default.htm),
and provides technical
recommendations to sponsors for the
electronic submission of standardized
animal and human study data and
related information contained in certain
submissions to new drug applications
(NDAs), abbreviated new drug
applications (ANDAs), biologic license
applications (BLAs), and investigational
new drug applications (INDs). The
eStudy Data guidance implements the
electronic submission requirements of
section 745A(a) of the Federal Food,
Drug, and Cosmetic Act (which was
added by section 1136 of the Food and
Drug Administration Safety and
Innovation Act (Pub. L. 112–144)) for
standardized study data contained in
NDA, ANDA, BLA, and IND
submissions.
The Guide is intended to complement
and promote interactions between
sponsors and FDA review divisions. It is
not intended to replace the need for
sponsors to communicate directly with
review divisions regarding data
standards implementation approaches
or issues.
The Guide is organized as follows:
Section 1: ‘‘Introduction’’—provides
information on regulatory policy and
PO 00000
Frm 00016
Fmt 4703
Sfmt 4703
guidance background, purpose, and
document control.
Section 2: ‘‘Planning and Providing
Standardized Study Data’’—
recommends and provides details on
preparing an overall study data
standardization plan, a study data
reviewer’s guide, and an analysis data
reviewer’s guide.
Section 3: ‘‘Exchange Format—
Electronic Submissions’’—presents the
specifications, considerations, and
recommendations for the file formats
currently supported by FDA.
Section 4: ‘‘Study Data Submission
Format: Clinical and Nonclinical’’—
presents general considerations and
specifications for sponsors using, for
example, the following standards for the
submission of study data: Study Data
Tabulation Model (SDTM), Analysis
Data Model (ADaM), and Standard for
Exchange of Nonclinical Data (SEND).
Section 5: ‘‘Therapeutic Area
Standards’’—presents supplemental
considerations and specific
recommendations when sponsors
submit study data using FDA-supported
therapeutic area standards.
Section 6: ‘‘Terminology’’—presents
general considerations and specific
recommendations when using
controlled terminologies/vocabularies
for clinical trial data.
Section 7: ‘‘Electronic Submission
Format’’—provides specifications and
recommendations on submitting study
data using the electronic Common
Technical Document format.
Section 8: ‘‘Data Validation and
Traceability’’—provides general
recommendations on conformance to
standards, data validation rules, data
traceability expectations, and legacy
data conversion.
In the Federal Register of February 6,
2014 (79 FR 7201), FDA announced the
availability of Version 1.0 of the Study
Data Technical Conformance Guide. The
comment period on the Guide ended on
May 7, 2014. We reviewed all comments
received and revised it accordingly.
Updates to Version 2.0 include, but are
not limited to:
Section 2: Added a subsection to
include an Analysis Data Reviewer’s
Guide.
Section 3: Clarified dataset sizes,
column lengths, special characters for
variables, and datasets.
Section 4: Clarified general
considerations and domain
specifications for SDTM and ADaM.
Section 6: Clarified a number of
subsections, including controlled
terminology, medications,
pharmacologic class, and indication,
and added a World Health Organization
Drug Dictionary.
E:\FR\FM\12JAN1.SGM
12JAN1
Federal Register / Vol. 80, No. 7 / Monday, January 12, 2015 / Notices
Section 7: Clarified the electronic
submission format and the folder
structure for study datasets.
Section 8: Renamed the section ‘‘Data
Validation and Traceability’’ from ‘‘Data
Fitness’’ and clarified several of the
subsections, including Traceability
Issues and Legacy Data Conversion.
II. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments 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.
III. Electronic Access
Persons with access to the Internet
may obtain the Guide and the Catalog at
either https://www.fda.gov/forindustry/
datastandards/studydatastandards/
default.htm or https://
www.regulations.gov.
Dated: January 6, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–00206 Filed 1–9–15; 8:45 am]
DEPARTMENT OF HOMELAND
SECURITY
Customs and Border Protection
[CBP Dec. No. 15–01]
Expansion of Global Entry Eligibility to
Citizens of the Republic of Panama
U.S. Customs and Border
Protection; Department of Homeland
Security.
ACTION: General notice.
AGENCY:
U.S. Customs and Border
Protection (CBP) has established the
Global Entry international trusted
traveler program at most major U.S.
airports. Global Entry allows preapproved, low-risk participants
expedited entry into the United States
using Global Entry kiosks located at
designated airports. Currently,
eligibility for participation in Global
Entry is limited to U.S. citizens, U.S.
nationals, U.S. lawful permanent
residents, Mexican nationals, and
certain eligible citizens of the
Netherlands, the Republic of Korea, the
tkelley on DSK3SPTVN1PROD with NOTICES
VerDate Sep<11>2014
17:35 Jan 09, 2015
Jkt 235001
Global Entry Program
Global Entry is a voluntary program
that allows for the expedited clearance
of pre-approved, low-risk travelers
arriving in the United States at Global
Entry kiosks located at designated
airports. CBP issued the final rule that
promulgated the regulation to establish
Global Entry as an ongoing voluntary
regulatory program in the Federal
Register (77 FR 5681) on February 6,
2012. The final rule contains a detailed
description of the program, the
eligibility criteria, the application and
selection process, and the initial airport
locations. See 8 CFR 235.12. Travelers
who wish to participate in Global Entry
must apply via the Global On-Line
Enrollment System (GOES) Web site,
https://goes-app.cbp.dhs.gov, and pay
the applicable fee. Applications for
Global Entry must be completed and
submitted electronically.
Eligibility for participation in Global
Entry is limited to U.S. citizens, U.S.
nationals, U.S. lawful permanent
residents, and certain nonimmigrant
aliens from countries that have entered
into arrangements with CBP regarding
international trusted traveler programs.
Specifically, the regulation provides
that certain nonimmigrant aliens from
countries that have entered into
arrangements with CBP concerning
international trusted traveler programs
may be eligible to apply for
participation in Global Entry after CBP
announces the arrangement by
publication of a notice in the Federal
Register. The notice will include the
country, the scope of eligibility of
nonimmigrant aliens from that country
(e.g., whether only citizens of the
foreign country or citizens and noncitizens are eligible) and other
conditions that may apply based on the
terms of the arrangement. See 8 CFR
235.12(b)(1)(ii). In the preamble of the
Global Entry final rule, CBP recognized
the existence of previous arrangements
it had with Mexico and the Netherlands
regarding the international trusted
traveler programs and announced that
Mexican nationals and certain citizens
of the Netherlands were eligible to
apply for the Global Entry program. It
further specified that Mexican nationals
and citizens of the Netherlands who
were existing participants in the Global
Entry pilot would be automatically
enrolled in the ongoing Global Entry
program. Additionally, in the preamble
of the Global Entry final rule, CBP
recognized that pursuant to a previous
Federal Register notice,2 participants in
NEXUS and certain participants in
SENTRI would still be allowed to use
the Global Entry kiosks.
In a notice published in the Federal
Register (78 FR 48706) on August 9,
2013, CBP expanded Global Entry
eligibility to include citizens of the
Republic of Korea who are participants
in the Smart Entry System (SES), a
trusted traveler program for preapproved, low-risk travelers at
designated airports in the Republic of
Korea via the use of e-gates; a limited
number of citizens of the Federal
Republic of Germany who are
participants in the Automated and
Biometrics-Supported Border Controls
(ABG) Plus, a trusted traveler program
in the Federal Republic of Germany; a
limited number of citizens of the State
of Qatar; and a limited number of
citizens of the United Kingdom who
frequently travel to the United States.
This document announces the further
expansion of the Global Entry trusted
1 See the Utilization of Global Entry Kiosks by
NEXUS and SENTRI Participants Federal Register
notice, December 29, 2010 (75 FR 82202) for further
information.
2 See the Utilization of Global Entry Kiosks by
NEXUS and SENTRI Participants Federal Register
notice, December 29, 2010 (75 FR 82202) for further
information.
Background
BILLING CODE 4164–01–P
SUMMARY:
Federal Republic of Germany, the State
of Qatar, and the United Kingdom.
Additionally, participants in the NEXUS
trusted traveler program and certain
participants in the Secure Electronic
Network for Travelers Rapid Inspection
(SENTRI) trusted traveler program are
permitted to use the Global Entry kiosks
as part of their membership in those
programs.1 This document announces
that CBP is expanding eligibility for
Global Entry to include citizens of the
Republic of Panama. All of these
individuals must otherwise satisfy the
requirements for participation in the
Global Entry program. Additionally, this
document announces that U.S. citizens
who participate in Global Entry or U.S.
citizens who can utilize Global Entry
kiosks as NEXUS or SENTRI
participants have the option to apply for
membership in Panama Global Pass, the
Republic of Panama’s trusted traveler
program.
DATES: The expansion of eligibility to
citizens of the Republic of Panama will
occur on January 12, 2015. Applications
will be accepted from citizens of the
Republic of Panama beginning January
12, 2015.
FOR FURTHER INFORMATION CONTACT:
Larry Panetta, Office of Field
Operations, (202) 344–1253,
Larry.A.Panetta@cbp.dhs.gov.
SUPPLEMENTARY INFORMATION:
1509
PO 00000
Frm 00017
Fmt 4703
Sfmt 4703
E:\FR\FM\12JAN1.SGM
12JAN1
Agencies
[Federal Register Volume 80, Number 7 (Monday, January 12, 2015)]
[Notices]
[Pages 1508-1509]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-00206]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-D-0092]
Study Data Technical Conformance Guide and Data Standards
Catalog; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a Study Data Technical Conformance Guide, Version 2.0
(Guide), and an update to the Data Standards Catalog (Catalog). The
Guide supplements the final guidance for industry entitled ``Providing
Regulatory Submissions in Electronic Format--Standardized Study Data''
(eStudy Data guidance) and provides specifications and recommendations
for, as well as general considerations on, submitting standardized
study data using FDA-supported data standards specified in the Catalog.
The Guide is intended to complement and promote interactions between
sponsors and FDA review divisions.
DATES: Submit either electronic or written comments on these documents
at any time.
ADDRESSES: Submit written requests for a copy of the Study Data
Technical Conformance Guide and the Data Standards Catalog 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. Send one self-addressed adhesive
label to assist that office in processing your requests.
Submit electronic comments on the guidance 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 20993-0002, 301-
796-5333, ronald.fitzmartin@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of Version 2.0 of the Guide and
an update to the Catalog. The Guide supplements the final guidance for
industry entitled ``Providing Regulatory Submissions in Electronic
Format--Standardized Study Data'' (available at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm),
and provides technical recommendations to sponsors for the electronic
submission of standardized animal and human study data and related
information contained in certain submissions to new drug applications
(NDAs), abbreviated new drug applications (ANDAs), biologic license
applications (BLAs), and investigational new drug applications (INDs).
The eStudy Data guidance implements the electronic submission
requirements of section 745A(a) of the Federal Food, Drug, and Cosmetic
Act (which was added by section 1136 of the Food and Drug
Administration Safety and Innovation Act (Pub. L. 112-144)) for
standardized study data contained in NDA, ANDA, BLA, and IND
submissions.
The Guide is intended to complement and promote interactions
between sponsors and FDA review divisions. It is not intended to
replace the need for sponsors to communicate directly with review
divisions regarding data standards implementation approaches or issues.
The Guide is organized as follows:
Section 1: ``Introduction''--provides information on regulatory
policy and guidance background, purpose, and document control.
Section 2: ``Planning and Providing Standardized Study Data''--
recommends and provides details on preparing an overall study data
standardization plan, a study data reviewer's guide, and an analysis
data reviewer's guide.
Section 3: ``Exchange Format--Electronic Submissions''--presents
the specifications, considerations, and recommendations for the file
formats currently supported by FDA.
Section 4: ``Study Data Submission Format: Clinical and
Nonclinical''--presents general considerations and specifications for
sponsors using, for example, the following standards for the submission
of study data: Study Data Tabulation Model (SDTM), Analysis Data Model
(ADaM), and Standard for Exchange of Nonclinical Data (SEND).
Section 5: ``Therapeutic Area Standards''--presents supplemental
considerations and specific recommendations when sponsors submit study
data using FDA-supported therapeutic area standards.
Section 6: ``Terminology''--presents general considerations and
specific recommendations when using controlled terminologies/
vocabularies for clinical trial data.
Section 7: ``Electronic Submission Format''--provides
specifications and recommendations on submitting study data using the
electronic Common Technical Document format.
Section 8: ``Data Validation and Traceability''--provides general
recommendations on conformance to standards, data validation rules,
data traceability expectations, and legacy data conversion.
In the Federal Register of February 6, 2014 (79 FR 7201), FDA
announced the availability of Version 1.0 of the Study Data Technical
Conformance Guide. The comment period on the Guide ended on May 7,
2014. We reviewed all comments received and revised it accordingly.
Updates to Version 2.0 include, but are not limited to:
Section 2: Added a subsection to include an Analysis Data
Reviewer's Guide.
Section 3: Clarified dataset sizes, column lengths, special
characters for variables, and datasets.
Section 4: Clarified general considerations and domain
specifications for SDTM and ADaM.
Section 6: Clarified a number of subsections, including controlled
terminology, medications, pharmacologic class, and indication, and
added a World Health Organization Drug Dictionary.
[[Page 1509]]
Section 7: Clarified the electronic submission format and the
folder structure for study datasets.
Section 8: Renamed the section ``Data Validation and Traceability''
from ``Data Fitness'' and clarified several of the subsections,
including Traceability Issues and Legacy Data Conversion.
II. Comments
Interested persons may submit either electronic comments regarding
this document to https://www.regulations.gov or written comments 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.
III. Electronic Access
Persons with access to the Internet may obtain the Guide and the
Catalog at either https://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm or https://www.regulations.gov.
Dated: January 6, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-00206 Filed 1-9-15; 8:45 am]
BILLING CODE 4164-01-P