Federal Register / Vol. 75, No. 240 / Wednesday, December 15, 2010 / Notices 78259 

Dated: December 9, 2010. 

Leslie Kux, 

Acting Assistant, Commissioner for Policy. 

[FR Doc. 2010–31386 Filed 12–14–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0616] 

Draft Guidance for Industry on 

Codevelopment of Two or More 

Unmarketed Investigational Drugs for 

Use in Combination; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Codevelopment of 

Two or More Unmarketed 

Investigational Drugs for Use in 

Combination.’’ This guidance is 

intended to assist sponsors in the 

codevelopment of two or more novel 

(not previously marketed) drugs to be 

used in combination to treat a disease or 

condition. This guidance provides 

recommendations and advice on how to 

address certain scientific and regulatory 

issues that will arise during 

codevelopment. The guidance is not 

intended to apply to development of 

fixed-dose combinations of already 

marketed drugs or to development of a 

single new investigational drug to be 

used in combination with an approved 

drug or drugs. The guidance is also not 

intended to apply to vaccines, gene or 

cellular therapies, blood products, or 

medical devices. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by February 14, 

2011. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 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. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

Submit electronic comments on the 

draft guidance to http:// 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: 

Colleen Locicero, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm 4216, 

Silver Spring, MD 20993–0002, 301– 

796–1114. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Codevelopment of Two or More 

Unmarketed Investigational Drugs for 

Use in Combination.’’ The guidance is 

intended to assist sponsors interested in 

developing two or more novel (not 

previously marketed) drugs to be used 

in combination. Recent scientific 

advances have increased our 

understanding of the pathophysiological 

processes that underlie many complex 

diseases, such as cancer, cardiovascular 

disease, and infectious diseases. This 

increased understanding has provided 

further impetus for new therapeutic 

approaches that rely primarily or 

exclusively on combinations of drugs 

directed at multiple therapeutic targets 

to improve treatment response and 

minimize development of resistance. In 

settings in which combination therapy 

provides significant therapeutic 

advantages, there is growing interest in 

the development of combinations of 

investigational drugs not previously 

developed for any purpose. 

Because the existing developmental 

and regulatory paradigm focuses 

primarily on assessment of the 

effectiveness and safety of a single new 

investigational drug acting alone, or in 

combination with an approved drug, 

FDA believes guidance is needed to 

assist sponsors in the codevelopment of 

two or more unmarketed drugs. This 

guidance is intended to describe a highlevel, generally applicable approach to 

codevelopment of two or more 

unmarketed drugs. It describes the 

criteria for determining when 

codevelopment is an appropriate option, 

makes recommendations about 

nonclinical and clinical development 

strategies, and addresses certain 

regulatory process issues. The guidance 

does not apply to vaccines, gene or 

cellular therapies, or blood products. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the Agency’s current thinking 

on companion diagnostic devices. It 

does not create or confer any rights for 

or on any person and does not operate 

to bind FDA or the public. An 

alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed 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. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at either http: 

//www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm or http:// 

www.regulations.gov. 

Dated: December 9, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–31426 Filed 12–14–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0618] 

Statement of Organization, Functions 

and Delegations of Authority 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has reorganized 

its Center for Tobacco Products (CTP) by 

establishing two new offices: Office of 

Health Communication and Education 

and the Office of Compliance and 

Enforcement. In addition, CTP has made 

improvements to the current offices’ 

functional statements. This 

organizational change is intended to fill 

the gaps in the current CTP structure 

and clarify major responsibilities 

designed for long-term success in 

administering the Family Smoking 

Prevention and Tobacco Control Act. 


hsrobinson on DSK69SOYB1PROD with NOTICES
78260 Federal Register / Vol. 75, No. 240 / Wednesday, December 15, 2010 / Notices 

FOR FURTHER INFORMATION CONTACT: Erik 

Mettler, Office of Management; or 

Sharon Chartos, Office of Management, 

Center for Tobacco Products, Food and 

Drug Administration, 9200 Corporate 

Blvd., Rockville, MD 20850, 301–796– 

9200. 

I. Introduction 

The Statement of Organization, 

Functions and Delegations of Authority 

for the Center for Tobacco Products (74 

FR 41713, August 18, 2009) is amended 

to reflect the restructuring of the Center 

for Tobacco Products that was approved 

by the Secretary of Health and Human 

Services on November 15, 2010: 

II. Organization 

The Center for Tobacco Products is 

headed by the Director and includes the 

following organizational units: 

Center For Tobacco Products (DI) 

1. Oversees the implementation of the 

Family Smoking Prevention and 

Tobacco Control Act, which provides 

FDA with several new authorities. 

These include restricting the marketing 

of tobacco products to minors; requiring 

new warning labels for cigarettes and 

smokeless tobacco products; prohibiting 

marketing measures that are misleading 

to consumers; establishing tobacco 

product standards; requiring Good 

Manufacturing Practice standards for 

tobacco product manufacturing 

facilities; requiring industry reporting of 

tobacco product ingredient and 

constituent data, including a description 

of the nicotine content and delivery 

mechanisms; educating the public and 

regulated industry about various 

provisions of the Family Smoking 

Prevention and Tobacco Control Act; 

and enforcement authorities including 

but not limited to enabling FDA to act 

quickly and effectively to remove 

products that are in violation of the 

statute. 

2. Provides programmatic and policy 

direction to appropriate Center and 

Agency personnel on all matters related 

to implementation of the Family 

Smoking Prevention and Tobacco 

Control Act and identifies critical public 

health issues relating to tobacco product 

use. 

3. Establishes and maintains effective 

relationships with senior FDA, 

Department of Health and Human 

Services (HHS), and Administration 

officials, industry representatives, 

Members of Congress, counterparts from 

State, local, territorial, and tribal 

governments, representatives from 

academia and public health 

organizations, and other key 

stakeholders on matters related to 

tobacco products. 

Office of the Center Director (DIA) 

1. Provides vision, leadership, and 

strategic direction for all Center 

activities related to regulation of tobacco 

products and implementation of the 

Family Smoking Prevention and 

Tobacco Control Act. 

2. Provides vision, leadership, and 

strategic direction for all Center 

activities related to protecting the public 

health and communicating about the 

negative consequences of tobacco 

product use. 

3. Plans, administers, coordinates, 

evaluates, and implements overall 

Center scientific, legal, policy, 

regulatory, compliance, public 

education, and management programs, 

policies, and plans. 

4. Provides leadership and direction 

for Center management, planning, and 

evaluation systems to ensure optimum 

utilization of personnel, budgetary and 

financial resources, information 

technology, professional development, 

and facilities. 

5. Establishes a program to maintain 

the highest levels of scientific quality 

and integrity for the Center. 

6. Serves as the primary liaison and 

spokesperson on tobacco products 

regulation and the public health 

consequences of tobacco products use 

with FDA, HHS, Office of Management 

and Budget (OMB), the White House, 

Congress and the media, as well as with 

a variety of stakeholders, including 

regulated industry; tobacco control 

advocacy organizations; scientific, 

public health, and medical associations; 

academia; and State, local, territorial, 

and tribal governments. 

7. Provides Center-wide program and 

strategic planning, execution, and 

support to Center leadership; 

coordination, development, clearance, 

and delivery of all Congressionally 

mandated reports, studies, and analyses; 

and also high quality briefing materials, 

background information for meetings, 

and speeches. 

8. Provides correspondence control 

for the Center and controls and 

processes all public correspondence. 

Develops and operates executive 

correspondence tracking systems. 

9. Manages the Center’s Freedom of 

Information Act activities, coordinating 

responses with other Center technical, 

legal, regulatory, and policy units as 

well as developing direct responses. 

10. Manages the Center’s Ombudsman 

program. 

11. Manages the Center’s history 

program and archives. 

Office of Management (DIB) 

1. Provides authoritative advice and 

guidance to the Center Director on 

management policies, guidelines, issues 

and concerns that impact Center 

programs and initiatives. 

2. Provides leadership, guidance, and 

direction regarding the development of 

long-range strategic management plans, 

operational plans, and systems for 

Center activities. Directs technical 

support staff in providing essential 

management services and other critical 

support functions. 

3. Provides leadership and guidance 

as primary liaison with the FDA Office 

of Management to ensure provision of a 

broad range of essential technical 

support services. 

4. Provides leadership and effective 

coordination as the primary Center 

liaison and expert with the Office of 

Information Management for provision 

and continuous improvement of 

information technology services to 

include networking, scientific 

computing software engineering, 

systems, and telecommunications. 

5. Designs and develops performance 

management systems and operational/ 

business process plans. 

6. Analyzes management performance 

trends, FDA cost structure, and use of 

program resources. 

7. Directs a variety of short-range and 

long-range special projects or 

assignments of substantial significance 

to the Center. 

8. Administers and executes the 

Center management and fiscal planning 

and performance activities, budget 

formulation and execution, payroll, 

accounting, and property management 

functions. 

9. Analyzes, formulates, and develops 

the annual budget for the Center in 

accordance with FDA, HHS, OMB, and 

Congressional guidelines. Provides 

oversight and ensures compliance with 

all regulations governing financial 

processes as outlined in FDA, HHS, 

OMB, and U.S. Government 

Accountability Office policies. Manages 

FDA, HHS, OMB, and Congressional 

inquiries regarding budget formulation 

and execution and required quarterly 

reports to Congressional Appropriations 

Committees. 

10. Develops, maintains, monitors, 

analyzes, and reports data to Center 

management and program officials on 

the Center’s budget/planning resource 

monitoring and evaluations systems. 

11. Provides leadership within the 

Center to ensure compliance with 

statutes, executive orders, and 

administrative directives, such as the 

Chief Financial Officer Act and the 


hsrobinson on DSK69SOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 240 / Wednesday, December 15, 2010 / Notices 78261 

Federal Financial Managers’ Financial 

Integrity Act. 

12. Serves as the liaison between the 

CTP and the Bethesda Field Office, 

Atlanta Field Office, and/or Office of 

Management Programs on all personnel 

issues including, but not limited to, 

Human Capital Resources, appointment 

mechanisms, recruitment flexibilities, 

Senior Executive Service (SES) 

appointments, Title 42 appointments, 

retention flexibilities, and position 

management. Manages the Center’s 

Performance Management program and 

the Center’s Awards program. 

13. Manages, tracks, and maintains 

the Center’s regulatory submissions in 

accordance with FDA’s records 

retention policies. 

14. Receives, tracks, and stores all of 

Center’s regulatory submissions. 

15. Manages, conducts, and analyzes 

studies designed to improve Center 

processes and resource utilization and 

support requirements. 

16. Manages facility-related activities 

for the Center including leases, space 

needs, maintenance, and development 

of architectural plans for move to FDA’s 

White Oak campus. 

17. Manages the Center’s employee 

training and development activities, 

including individual employee 

development plans. Manages the 

Center’s regulatory science fellowship 

program and other academic-based 

fellowship programs. 

Office of Policy (DIC) 

1. Advises the Center Director and 

other key Agency officials on public 

health, scientific, and regulatory policy 

development at the Center. 

2. Develops and evaluates Centerwide priorities and policies, assuring 

FDA’s statutory public health goals and 

policy needs are integrated into 

initiatives across science, regulations, 

compliance, public education, and 

management programs across the 

Center. 

3. Ensures that Center policy 

decisions are consensus-based and 

informed, when relevant and 

appropriate, through communications 

with stakeholders in CTP, FDA, the 

Centers for Disease Control and 

Prevention, National Institutes for 

Health, HHS, and other government and 

relevant stakeholders and private 

agencies. 

4. Monitors, coordinates, and advises 

the Center Director on policy involving 

sensitive, controversial, and complex 

issues related to Center activities that 

may involve precedent-setting matters 

or issues of particular concern to the 

Center Director or FDA Commissioner of 

Food and Drugs. 

5. Analyzes and evaluates the impact 

and effectiveness of the Center’s overall 

impact on public health. 

6. Oversees public health policy and 

analytics; coordinates and conducts 

contingency analyses; manages special 

projects that require quick reaction/ 

problem solving and planning; and 

develops and oversees the Center’s 

approach to evolving issues in tobacco 

product regulation and control, such as 

impact on population health, 

development of policy aspects of 

tobacco product standards, modified 

risk products, substantial equivalence, 

and marketing and advertising. 

7. Provides economic and modeling 

analyses on policy options as required. 

8. Provides authoritative policy 

advice, guidance, assistance, 

interpretations, and recommendations 

to CTP, FDA, HHS officials, and 

scientific and professional personnel, 

intra-governmental counterparts (State, 

territorial and tribal officials). 

9. Prepares and reviews legislative 

proposals, Congressional testimony; and 

materials related to implementing, 

amending, or modifying the Family 

Smoking Prevention and Tobacco 

Control Act, FDA laws, and regulations 

in collaboration with the Office of the 

Commissioner, Office of Legislation. 

10. Provides advice and analysis for 

international tobacco control policies 

and acts as the Center’s liaison with 

international stakeholders, including 

foreign governments. 

11. Advises external stakeholders, 

including large and small tobacco 

manufacturers, tobacco control 

advocacy groups, medical and 

professional trade associations, State, 

territorial, local, and tribal governments, 

and others concerning the policy 

implications of the law and regulations. 

12. Manages the Center’s small 

business assistance activities. 

Office of Regulations (DID) 

1. Provides Center’s oversight and 

leadership in, and coordinates the 

development of regulations, policies, 

procedures, and guidance related to the 

regulation of tobacco products. 

2. Reviews and clears draft 

regulations developed by the Center, 

other FDA Centers, and other agencies. 

3. Provides Center-level leadership 

and coordination for briefings within 

FDA, and with HHS, OMB, and other 

Federal agencies related to regulations 

and guidance documents. 

4. Serves as the Center’s focal point 

for developing and maintaining 

communications, policies, and programs 

with regard to regulations development, 

review, clearance, and publication. 

5. Serves as the Center’s primary 

liaison with the FDA’s Office of Chief 

Counsel and the HHS Office of General 

Counsel; and provides support for legal 

defense in litigation. 

6. Manages the development and 

implementation of plans for the Center’s 

regulation development activities. 

7. Provides technical assistance on the 

development of legislative proposals 

related to FDA responsibilities of the 

Family Smoking Prevention and 

Tobacco Control Act. 

8. Manages the citizens’ petition 

process on behalf of the Center. 

9. Supports the Center in its 

regulatory litigation activities. 

Office of Science (DIE) 

1. Conducts scientific research and 

reviews programs to support the 

Center’s goals for implementing the 

Family Smoking Prevention and 

Tobacco Control Act, as part of a 

comprehensive effort to reduce the toll 

of disease, disability, and death caused 

by tobacco products. 

2. Serves as the focal point for overall 

management of Center activities related 

to science priorities and resources. 

Advises and assists the Center Director, 

FDA Commissioner of Food and Drugs, 

and other key officials on scientific 

issues that have an impact on public 

health, policy, direction, and long-range 

goals, and on the functions, capabilities, 

and management of scientific research 

facilities; and participates with other 

Agency components in planning such 

facilities. 

3. Coordinates the Tobacco Products 

Scientific Advisory Committee which 

advises the Center Director, FDA 

Commissioner of Food and Drugs, HHS 

Secretary of Health and Human 

Services, and other key officials on 

certain issues related to the public 

health impact of tobacco products. 

4. Organizes, plans, directs, and 

conducts research related to the 

development, manufacture, testing, 

labeling, and marketing of tobacco 

products in order to develop and 

maintain a scientific base for 

establishing policies, tobacco product 

standards, and test methods appropriate 

for the protection of public health. 

5. Plans, directs, and conducts 

epidemiological research regarding the 

initiation, use, and cessation of tobacco 

products and the impact on the public 

health. 

6. Coordinates targeted research to 

address Center priorities in 

collaboration with leading scientists in 

other segments of FDA, other Federal 

agencies, and the scientific community 

at large. 


hsrobinson on DSK69SOYB1PROD with NOTICES
78262 Federal Register / Vol. 75, No. 240 / Wednesday, December 15, 2010 / Notices 

7. Plans, directs, and conducts 

research related to behavioral science, 

including consumer behavior and 

consumer perception of risks of harm 

from tobacco products. 

8. Establishes and publishes a list of 

harmful and potentially harmful 

constituents in each regulated tobacco 

product. 

9. Develops policies and procedures 

governing the submission and review of 

ingredient and constituent information 

for regulated tobacco products and 

oversees their implementation. 

10. Develops and implements policies 

and procedures governing the 

submission and review of applications 

and postmarketing surveillance studies 

for modified-risk tobacco products. 

11. Develops and implements policies 

and procedures governing the 

submission and premarket review of 

reports of substantially equivalent 

tobacco products and applications for 

new tobacco products. 

12. Develops and implements policies 

and procedures governing submission 

and review of information regarding 

investigational tobacco products. 

13. Develops, maintains, monitors, 

and analyzes policies, programs, and 

databases of adverse reactions to 

tobacco products. 

14. Reviews, evaluates, and takes 

appropriate action on recommendations 

concerning denial or withdrawal of 

marketing and modified-risk 

authorizations for tobacco products. 

15. Develops, in coordination with 

other Center offices, standards for Good 

Manufacturing Practices regarding 

methods, facilities, and controls for 

manufacturing, testing, and storage of 

tobacco products. 

16. Participates, in coordination with 

other Agency components, in 

inspections of manufacturing facilities 

for compliance with applicable 

manufacturing and tobacco product 

standards. 

17. Represents the Center in 

interactions with other government 

agencies, State and local governments, 

industry, academia, consumer 

organizations, Congress, national and 

international organizations, and the 

scientific community on tobacco science 

and regulation issues. 

18. Coordinates and provides 

guidance on science policy in program 

areas that cross major Agency 

component lines and on scientific 

aspects of critical or controversial 

issues, including Agency risk 

assessment policies. 

Office of Health Communication and 

Education (DIF) 

1. Serves as a comprehensive health 

communication enterprise developed as 

a part of a comprehensive effort to 

reduce the toll of disease, disability, and 

death caused by tobacco products. 

2. Develops, coordinates, and 

evaluates public health communication 

and education activities in support of 

requirements of the Family Smoking 

Prevention and Tobacco Control Act. 

3. Serves as the central point for 

communication about the Center’s 

activities, campaigns, and key messages, 

including executing programs and 

implementing strategies about the 

regulation of tobacco products and the 

health risks associated with tobacco 

product use. 

4. Ensures consistent branding, 

messaging, and strategic 

communications for all Center public 

education output. 

5. Provides effective collaboration and 

coordination with partners and 

stakeholders on public health education 

and communications programs. 

6. Provides accurate and timely public 

health information and education about 

tobacco products regulation and the 

requirements of the Family Smoking 

Prevention and Tobacco Control Act. 

7. Develops and manages 

informational materials for health 

professionals and consumers, including 

Web pages and print media. 

8. Manages Center’s Web sites 

(Intranet and Internet). 

9. Constructs risk communication 

messages in support of the requirements 

of the Family Smoking Prevention and 

Tobacco Control Act, using appropriate 

research methods. 

10. Serves as the liaison between the 

Center and its stakeholders on public 

health education and communication 

programs. 

Office of Compliance and Enforcement 

(DIG) 

1. Advises the Center Director and 

other Agency officials on legal, 

administrative, and regulatory programs 

and policies concerning Agency 

compliance and enforcement 

responsibilities relating to tobacco 

products. 

2. Coordinates, interprets, and 

evaluates the Center’s overall 

compliance and enforcement efforts. 

3. Provides technical support and 

guidance in the development and 

review of standards, regulations, and 

guidance related to compliance and 

enforcement. 

4. Develops, directs, coordinates, 

evaluates, and monitors compliance and 

enforcement programs covering 

regulated industry. 

5. Coordinates, develops, and directs 

State compliance and enforcement 

programs. 

6. Provides training of Federal, State, 

and territorial compliance personnel. 

7. Conducts field tests and 

inspections when necessary for 

regulatory purposes and evaluates 

regulated industry activities to assure 

compliance with regulations. 

8. Provides advice to Agency field 

offices and commissioned officials, and 

manages Center activities relating to 

legal actions, case development, and 

contested case assistance. 

9. Designs, develops, and implements 

Center programs to register tobacco 

establishments and product lists. 

10. Coordinates all field planning 

activities and issues all field 

assignments for the Center. 

11. Advises actual or potential 

manufacturers, distributors, retailers, 

and importers concerning the 

requirements of the law and regulations 

related to compliance and enforcement. 

III. Delegation of Authority 

Pending further delegation, directives, 

or orders by the Commissioner of Food 

and Drugs, or the Director of Center for 

Tobacco Products, all delegations and 

redelegations of authority made to 

officials and employees of affected 

organizational components in effect 

prior to this date will continue in effect 

in them or their successors, provided 

they are consistent with this 

reorganization. 

Dated: December 9, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–31383 Filed 12–14–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Transportation Security Administration 

Intent To Request Approval From OMB 

of One New Public Collection of 

Information: Airport Federalization 

AGENCY: Transportation Security 

Administration, DHS. 

ACTION: 60-day notice. 

SUMMARY: The Transportation Security 

Administration (TSA) invites public 

comment on a new Information 

Collection Request (ICR) (abstracted 

below) that we will submit to the Office 

of Management and Budget (OMB) for 

approval in compliance with the 

Paperwork Reduction Act (PRA). The 


hsrobinson on DSK69SOYB1PROD with NOTICES