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 http://

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. 

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 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. 

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 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 20993–0002, 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 http://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 

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. 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 7 / Monday, January 12, 2015 / Notices 1509 

1See the Utilization of Global Entry Kiosks by 

NEXUS and SENTRI Participants Federal Register 

notice, December 29, 2010 (75 FR 82202) for further 

information. 

2See the Utilization of Global Entry Kiosks by 

NEXUS and SENTRI Participants Federal Register 

notice, December 29, 2010 (75 FR 82202) for further 

information. 

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 http://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 http://

www.regulations.gov. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the Guide and the Catalog at 

either http://www.fda.gov/forindustry/

datastandards/studydatastandards/

default.htm or http://

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 

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 

AGENCY: U.S. Customs and Border 

Protection; Department of Homeland 

Security. 

ACTION: General notice. 

SUMMARY: 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 

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: 

Background 

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 


tkelley on DSK3SPTVN1PROD with NOTICES