78856 Federal Register / Vol. 85, No. 235 / Monday, December 7, 2020 / Notices 

Form Number: CMS–10733 (OMB 

control number: 0938–New); Frequency: 

Annually; Affected Public: Private 

Sector, State, Local, or Tribal 

Governments, Federal Government, 

Business or other for-profits, Not-forprofits institutions; Number of 

Respondents: 1,000; Total Annual 

Responses: 1,000; Total Annual Hours: 

1,500. (For policy questions regarding 

this collection contact James Krometis at 

410–786–0340.) 

Dated: December 2, 2020. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2020–26859 Filed 12–4–20; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Office of Child Support Enforcement; 

Statement of Organization, Functions, 

and Delegations of Authority 

AGENCY: Administration for Children 

and Families, HHS. 

ACTION: Notice. 

SUMMARY: Statement of Organization, 

Functions, and Delegations of 

Authority. 

The Administration for Children and 

Families (ACF) has reorganized the 

Office of Child Support Enforcement. 

This reorganization realigns the 

functions of the Office of Child Support 

Enforcement. It eliminates the Division 

of Performance and Statistical Analysis 

and moves the functions to the Division 

of Federal Systems. 

FOR FURTHER INFORMATION CONTACT: 

Scott Lekan, Acting Commissioner, 

Office of Child Support Enforcement, 

330 C Street SW, Washington, DC 

20201; (202) 401–9369. 

SUPPLEMENTARY INFORMATION: This 

notice amends Part K of the Statement 

of Organization, Functions, and 

Delegations of Authority of the 

Department of Health and Human 

Services (HHS), Administration for 

Children and Families (ACF), as 

follows: Chapter KF, Office of Child 

Support Enforcement (OCSE), as last 

amended in 78 FR 60880—60883, 

October 2, 2013. 

I. Under Chapter KF, Office of Child 

Support Enforcement, delete KF in its 

entirety and replace with the following: 

KF.00 MISSION. The Office of Child 

Support Enforcement (OCSE) advises 

the Secretary, through the Assistant 

Secretary for Children and Families/ 

Director of the Office of Child Support 

Enforcement, on matters pertaining to 

the child support and access and 

visitation programs. OCSE provides 

direction, guidance, and oversight to 

state and tribal child support programs, 

the Central Authority for international 

child support cases, and state access 

and visitation programs for activities 

authorized and directed by title IV–D of 

the Social Security Act and other 

pertinent legislation. OCSE’s core 

mission is dedicated to establishing 

paternity and obtaining child support in 

order to encourage responsible 

parenting, family self-sufficiency, and 

child well-being, and to recognize the 

essential role of both parents in 

supporting their children. The national 

child support program assures that 

assistance in obtaining support, 

including financial and medical, is 

available to children, through locating 

parents, establishing paternity, 

establishing and modifying support 

obligations, and monitoring and 

enforcing those obligations. The specific 

responsibilities of this Office are to 

develop, recommend, and issue 

policies, procedures, and interpretations 

for state and tribal programs for locating 

noncustodial parents, establishing 

paternity, and obtaining child support; 

develop procedures for review and 

approval or disapproval of state and 

tribal plan material; conduct audits of 

state child support programs; assist 

states and tribes in establishing 

adequate reporting procedures and 

maintaining records for the operation of 

their child support programs and of 

amounts collected and disbursed under 

the child support program and the costs 

incurred in collecting such amounts; 

operate the United States and Tribes 

Central Authority for International 

Child Support; monitor the access and 

visitation and fatherhood programs; and 

provide technical assistance and 

training to the states and tribes to help 

them develop effective procedures and 

systems for services provided by the 

child support program, including 

automation, outreach, referral, and case 

management in partnership with 

employers, courts, and responsible 

fatherhood, workforce, and other 

programs to increase the long-term 

reliability of support payments available 

to children. OCSE also operates 

competitive grant programs for child 

support in collaboration with several 

other components within ACF. It also 

operates the Federal Parent Locator 

Service (FPLS); certifies to the Secretary 

of the Treasury amounts of child 

support obligations that require 

collection in appropriate instances; 

transmits to the Secretary of State 

certifications of arrearages for passport 

denial; submits reports to Congress, as 

requested, on activities undertaken 

relative to the child support program; 

approves advance data processing 

planning documents; and reviews, 

assesses, and inspects planning, design, 

and operation of state and tribal 

management information systems. FPLS 

also assists other federal, state, and local 

agencies not involved in child support 

to fulfill their respective missions, save 

taxpayer dollars, and improve service to 

the public. 

KF.10 ORGANIZATION. The Office of 

Child Support Enforcement is headed 

by the Director. The office is organized 

as follows: 

Office of the Director/Deputy Director/ 

Commissioner (KFA) 

Office of Audit (KFAA) 

Office of the Deputy Commissioner 

(KFB) 

Division of Business and Resource 

Management (KFB2) 

Division of Customer Communications 

(KFB3) 

Division of Policy and Training (KFB5) 

Division of Program Innovation (KFB7) 

Division of Regional Operations (KFB8) 

Child Support Services Regional 

Program Units (KFB8DI–X) 

Division of Federal Systems (KFB9) 

Division of State and Tribal Systems 

(KFB10) 

KF.20 FUNCTIONS. Office of the 

Director and Deputy Director/ 

Commissioner (KFA): The Director is 

also the Assistant Secretary for Children 

and Families and is directly responsible 

to the Secretary for carrying out OCSE’s 

mission. The Deputy Director/ 

Commissioner has day-to-day 

operational responsibility for OCSE. The 

Deputy Director/Commissioner assists 

the Director in carrying out 

responsibilities of the Office and 

provides direction and leadership to the 

Office of the Deputy Commissioner and 

the Office of Audit. 

The Deputy Director/Commissioner 

provides leadership and direction to 

OCSE and is responsible for developing 

regulations, guidance, and standards for 

state/tribes to follow in locating absent 

parents; establishing paternity and 

support obligations; maintaining 

relationships with Department officials, 

other federal departments, state and 

tribal and local officials, and private 

organizations and individuals interested 

in the child support program; 

coordinating and planning child 

support program activities to maximize 

program effectiveness; program 

outreach, as well as access and 


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visitation programs and advocacy 

interests; and approving all instructions, 

policies, and publications. The Deputy 

Director/Commissioner is also 

responsible for the operations and 

maintenance of FPLS, management and 

financial analysis and strategy 

development, internal OCSE operations, 

and compliance with federal laws and 

policies. The Deputy Director/ 

Commissioner is responsible for 

collaborating with the Office of 

Legislative Affairs and Budget and the 

Government Accountability Office on 

studies related to the child support 

program. In addition, the Deputy 

Director/Commissioner maintains 

OCSE’s Continuity of Operations Plan. 

Office of Audit (KFAA): The Office of 

Audit develops, plans, schedules, and 

conducts periodic audits of child 

support programs in accordance with 

audit standards promulgated by the 

Comptroller General. The office is 

headed by an Office Director and reports 

directly to the Commissioner. The 

Office conducts audits, at least once 

every 3 years (or more frequently if it is 

determined that a state has unreliable 

data or fails to meet the performance 

standards) to determine the reliability of 

state financial and statistical data 

reporting systems used in calculating 

the performance indicators used as the 

basis for the payment of performancebased financial incentives to the state. 

These audits include testing of the data 

produced by the system to ensure that 

it is valid, complete, and reliable. The 

audits also include a review of the 

state’s physical security and access 

controls. 

The Office will also conduct financial 

audits to determine whether federal and 

other funds made available to carry out 

the child support program are being 

appropriately expended, and properly 

and fully accounted for. These audits 

will also examine collections and 

disbursements of support payments for 

proper processing and accounting. In 

addition, the Office will also conduct 

other audits and examinations of 

program operations, as may be 

necessary or requested by program 

officials for the purpose of improving 

the efficiency, effectiveness, and 

economy of state, tribal, and local child 

support activities. 

The Office develops consolidated 

reports for the Commissioner, based on 

findings, provides specifications for the 

development of audit regulations and 

requirements for audits of state 

programs, and coordinates and 

maintains effective liaison with the HHS 

Inspector General’s Office and with the 

Government Accountability Office. 

Office of the Deputy Commissioner 

(KFB): The Deputy Commissioner 

reports to the Deputy Director/ 

Commissioner and assists the 

Commissioner in carrying out the 

responsibilities of OCSE. The Deputy 

Commissioner provides day-to-day 

supervision and oversight of the 

Division of Business and Resource 

Management, Division of Customer 

Communications, Division of Policy and 

Training, Division of Program 

Innovation, Division of Regional 

Operations, Division of Federal 

Systems, and Division of State and 

Tribal Systems. The Deputy 

Commissioner leads OCSE outreach 

efforts and builds collaborations with 

federal, state, tribal, local, and 

community agencies to efficiently 

improve child support services. 

The Office of the Deputy 

Commissioner provides coordination for 

all OCSE contracts and internal IT 

systems. 

Division of Business and Resource 

Management (KFB2): The Division of 

Business and Resource Management 

(DBRM) is responsible for the overall 

management and operation of OCSE 

administrative services. The Division is 

headed by a Division Director who 

reports directly to the Deputy 

Commissioner. DBRM leads all efforts 

related to personnel and the formulation 

and execution of the discretionary 

budgets for OCSE program funds and 

federal administration funds. DBRM 

develops, implements, and manages all 

personnel activities; provides guidance 

on all labor and employee relations; 

coordinates performance management, 

employee engagement, and recognition; 

provides training and technical 

assistance on business administrative 

services; manages OCSE-controlled 

space, facilities, assets, and messenger 

services; and provides for health and 

safety. DBRM also serves as the funding 

authority for all OCSE acquisitions and 

grant opportunities, procures all goods 

and services, and coordinates all travel 

and conference management activities. 

Division of Customer 

Communications (KFB3): A Division 

Director leads the Division of Customer 

Communications (DCC) and reports to 

the Deputy Commissioner. The Division 

has two branches. The Customer Service 

branch responds to requests for 

information on specific child support 

cases from custodial and noncustodial 

parents, the White House, members of 

Congress, Office of Inspector General, 

state agencies, reciprocating countries, 

and various interest groups. The 

Program Communications branch plans, 

designs, and executes public outreach 

and communications campaigns to 

convey information about the child 

support program and engage with child 

support stakeholders. The branch is 

responsible for providing guidance on 

strategies and approaches to improve 

public understanding of and access to 

OCSE programs and policies, develops 

and publishes informational materials 

on the OCSE website, and engages with 

our stakeholders through social media. 

With these information channels, DCC 

serves as a focal point for consistent, 

clear, and accurate program 

communication. 

Division of Policy and Training 

(KFB5): The Division of Policy and 

Training (DPT) proposes and 

implements national policy for the child 

support program and provides policy 

guidance and interpretations to states 

and tribes in developing and operating 

their programs according to federal law. 

DPT is headed by a Division Director 

who directly reports to the Deputy 

Commissioner and is supported by the 

Policy Branch and the Training Branch. 

The Policy Branch develops legislative 

proposals and regulations to implement 

new legislation, court decisions, or 

directives from higher authority, and 

provides comments on pending 

legislative proposals. It develops new 

state plan preprint requirements and 

procedures for review and approval by 

the Division of Regional Operations. 

Additionally, the Policy Branch reviews 

the state plan submittals and prepares 

justifications for plan disapproval 

action. DPT coordinates with the Office 

of General Counsel on pending 

departmental appeals and collaborates 

with ACF on audit resolution. DPT also 

implements Central Authority activities 

for international support enforcement 

and functions as the U.S. Central 

Authority for international support 

enforcement. The Training Branch 

provides national direction and 

leadership for OCSE training activities 

to increase child support program 

effectiveness at federal, state, and tribal 

levels; coordinates child support 

program training activities; and 

provides logistical support for child 

support training events, meetings, and 

conferences. 

Division of Program Innovation 

(KFB7): The Division of Program 

Innovation (DPI) develops, evaluates, 

and refines new strategies to improve 

child support program effectiveness, 

and disseminates information about 

promising and evidence-based practice. 

The Division is headed by a Division 

Director who reports directly to the 

Deputy Commissioner. DPI manages 

research and demonstration projects, 

including Section 1115 grants and 

waivers and Special Improvement 


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78858 Federal Register / Vol. 85, No. 235 / Monday, December 7, 2020 / Notices 

Project grants, and promotes program 

evaluation at the state and local levels. 

DPI also implements special projects of 

regional or national significance, pilots 

new child support approaches, and 

administers the Access and Visitation 

Grant Program. 

The Division of Regional Operations 

(KFB8): The Division of Regional 

Operations (DRO) provides direct 

oversight of all child support Regional 

Program Unit operations, including 

ensuring customer-focused partnerships 

to child support programs and services, 

and implementation of child support 

regional operations, policies, budgets, 

and program compliance of all 10 

regions. This includes oversight of 

Regional Program Units providing 

technical assistance and support to state 

and tribal child support agencies. The 

Division is headed by a Director, who 

reports directly to the Deputy 

Commissioner. DRO provides 

management and oversight of the 

Regions through coordinating activities 

between Central Office Divisions and 

the Regional Program Units. The 

Division provides information to 

improve public understanding of and 

across to OCSE programs and policies. 

The Division is responsible for 

providing oversight of all Regional 

representation at conferences and 

meetings both within the child support 

community and other collaborative 

programs and partners. The Division is 

also responsible for the management, 

receipt, review, and analysis of public 

inquiries and the preparation of formal 

(both written and electronic) responses 

to external inquiries for child support 

program information and assistance in 

obtaining child support services. 

Child Support Enforcement Regional 

Program Units (KFB8DI–X): Each OCSE 

Regional Program Unit is headed by the 

OCSE Regional Program Manager who 

reports to the Director of the Division of 

Regional Operations. The OCSE 

Regional Program Manager, through 

regional staff and in collaboration with 

program stakeholders, is responsible for 

(1) providing program and technical 

administration of the ACF entitlement 

and discretionary programs related to 

OCSE; (2) collaborating with the ACF 

central office, states, tribes, and other 

external programs and grantees on all 

significant program and policy matters; 

(3) providing technical assistance and 

training to entities responsible for 

administering OCSE programs to resolve 

identified problems; (4) ensuring that 

appropriate procedures and practices 

are adopted; (5) working with 

appropriate state, tribal, and local 

offices to develop innovative practices 

to support family self-sufficiency; and 

(6) monitoring the programs to ensure 

their efficiency and effectiveness, and 

ensuring that these entities conform to 

federal laws, regulations, policies, and 

procedures governing the programs. 

Division of Federal Systems (KFB9): 

The Division of Federal Systems (DFS) 

is responsible for the design, 

development, deployment, 

maintenance, and implementation of 

FPLS. The Division is headed by a 

Division Director who directly reports to 

the Deputy Commissioner. FPLS is 

made up of a group of data sharing, 

collection, and program systems, such 

as the federal tax refund offset program, 

that helps OCSE support the core 

mission of the child support program 

and helps prevent improper payments 

in state and federal benefit programs 

through NDNH data matching. DFS 

provides states with data to help them 

locate parents, establish fair and 

equitable child support obligations, 

process income withholding and 

payments, collect and enforce past-due 

child support, and communicate 

effectively and efficiently. DFS provides 

outreach, technical support, and 

training to child support agencies, 

employers, insurers, financial 

institutions, and other private and 

government partners to ensure that the 

FPLS systems are used to their 

maximum benefit. 

DFS is responsible for automation of 

data and timeliness of transactions. 

Other responsibilities include, but are 

not limited to, oversight of 

collaborations with the Social Security 

Administration (SSA) on technical 

aspects of their use of OCSE’s data and 

OCSE’s use of SSA data center 

resources; conduct analyses and 

feasibility assessments; develop 

requirements; and design, develop, and 

implement system enhancements to 

increase efficiencies and support users 

of FPLS information. DFS also ensures 

that all IT projects are managed 

according to OMB/HHS/ACF standards 

for architecture, capital planning, 

security, and privacy, and fall within 

tolerances for acceptance. 

Additionally, DFS provides guidance, 

analysis, technical assistance, and 

oversight to state and tribal child 

support programs regarding 

performance measurement; statistical, 

policy, and program analysis; synthesis 

and dissemination of data sets to inform 

the program; and application of 

emerging technologies, such as business 

intelligence and data analytics to 

improve and enhance the effectiveness 

of programs and service. DFS is also 

responsible for collection, compilation, 

analysis, and dissemination of state and 

tribal data to Congress and the general 

public. The Division also provides 

statistical and budgeting support in 

coordination with other divisions. DFS 

is responsible for promoting public 

access and understanding of data; 

managing academic/research projects; 

and providing support for researchers. 

DFS provides technical assistance to 

states in developing their selfassessment capabilities and 

implementing the annual reporting 

requirements contained in the Personal 

Responsibility and Work Opportunity 

Reconciliation Act of 1996. 

Division of State and Tribal Systems 

(KFB10): The Division of State and 

Tribal Systems (DSTS) reviews, 

analyzes, and approves/disapproves 

state and tribal requests for Federal 

Financial Participation for automated 

systems development and operations 

activities that support the child support 

program. DSTS is headed by a Division 

Director who directly reports to the 

Deputy Commissioner. DSTS provides 

assistance to states and tribes in 

developing or modifying automation 

plans to conform to federal 

requirements. DSTS monitors approved 

state and tribal systems development 

activities; certifies state-wide automated 

systems; and conducts periodic reviews 

to assure state and tribal compliance 

with regulatory requirements applicable 

to automated systems supported by 

Federal Financial Participation. DSTS 

provides guidance to states and tribes 

on functional requirements for these 

automated information systems, and 

works with federal, state, local, and 

tribal health and human services 

agencies to foster and promote 

interoperability and collaboration across 

the automated systems that support 

their programs. The Division promotes 

interstate and tribal transfer of existing 

automated systems and provides 

assistance and guidance to improve 

ACF’s programs through the use of 

automated systems and technology. It 

provides development support and 

guidance to tribes on the installation, 

implementation, and maintenance of the 

Model Tribal System. 

II. Continuation of Policy. Except as 

inconsistent with this reorganization, all 

statements of policy and interpretations 

with respect to organizational 

components affected by this notice 

within ACF, heretofore issued and in 

effect on this date of this reorganization 

are continued in full force and effect. 

III. Delegation of Authority. All 

delegations and redelegations of 

authority made to officials and 

employees of affected organizational 

components will continue in them or 

their successors pending further 


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Federal Register / Vol. 85, No. 235 / Monday, December 7, 2020 / Notices 78859 

redelegations, provided they are 

consistent with this reorganization. 

IV. Funds, Personnel, and Equipment. 

Transfer of organizations and functions 

affected by this reorganization shall be 

accompanied in each instance by direct 

and support funds, positions, personnel, 

records, equipment, supplies, and other 

resources. 

This reorganization will be effective 

upon date of signature. 

Authority: 42 U.S.C. 652 

Dated: December 1, 2020. 

Megan E. Steel, 

Office of the Executive Secretariat, 

Administration for Children and Families. 

[FR Doc. 2020–26778 Filed 12–4–20; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–0026] 

Issuance of Priority Review Voucher; 

Rare Pediatric Disease Product 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

issuance of a priority review voucher to 

the sponsor of a rare pediatric disease 

product application. The Federal Food, 

Drug, and Cosmetic Act (FD&C Act), as 

amended by the Food and Drug 

Administration Safety and Innovation 

Act (FDASIA), authorizes FDA to award 

priority review vouchers to sponsors of 

approved rare pediatric disease product 

applications that meet certain criteria. 

FDA is required to publish notice of the 

award of the priority review voucher. 

FDA has determined that DANYELZA 

(naxitamab-gqgk) manufactured by YmAbs Therapeutics, Inc., (Cato Research 

LLC., US Agent) meets the criteria for a 

priority review voucher. 

FOR FURTHER INFORMATION CONTACT: 

Althea Cuff, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993–0002, 

301–796–4061, FAX: 301–796–9856, 

email: althea.cuff@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: FDA is 

announcing the issuance of a priority 

review voucher to the sponsor of an 

approved rare pediatric disease product 

application. Under section 529 of the 

FD&C Act (21 U.S.C. 360ff), which was 

added by FDASIA, FDA will award 

priority review vouchers to sponsors of 

approved rare pediatric disease product 

applications that meet certain criteria. 

FDA has determined that DANYELZA 

(naxitamab-gqgk) manufactured by YmAbs Therapeutics, Inc., (Cato Research 

LLC., US Agent), meets the criteria for 

a priority review voucher. 

DANYELZA (naxitamab-gqgk) 

indicated, in combination with 

granulocyte-macrophage colonystimulating factor (GM–CSF), for the 

treatment of pediatric patients 1 year of 

age and older and adult patients with 

relapsed or refractory high-risk 

neuroblastoma in the bone or bone 

marrow who have demonstrated a 

partial response, minor response, or 

stable disease to prior therapy. 

For further information about the Rare 

Pediatric Disease Priority Review 

Voucher Program and for a link to the 

full text of section 529 of the FD&C Act, 

go to http://www.fda.gov/ForIndustry/ 

DevelopingProductsforRareDiseases

Conditions/RarePediatricDiseasePriority

VoucherProgram/default.htm. For 

further information about DANYELZA 

(naxitamab) go to the ‘‘Drugs@FDA’’ 

website at http://

www.accessdata.fda.gov/scripts/cder/ 

daf/. 

Dated: December 1, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–26801 Filed 12–4–20; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–N–5900] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Endorser Status 

and Explicitness of Payment in Directto-Consumer Promotion 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing that a proposed collection 

of information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by January 6, 

2021. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comment’’ or 

by using the search function. The title 

of this information collection is 

‘‘Endorser Status and Explicitness of 

Payment in Direct-to-Consumer 

Promotion.’’ Also include the FDA 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: Ila 

S. Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 

Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–7726, PRAStaff@

fda.hhs.gov. 

For copies of the questionnaires 

contact: Office of Prescription Drug 

Promotion (OPDP) Research Team, 

DTCresearch@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Endorser Status and Explicitness of 

Payment in Direct-to-Consumer 

Promotion 

OMB Control Number 0910—NEW 

I. Background 

Section 1701(a)(4) of the Public 

Health Service Act (42 U.S.C. 

300u(a)(4)) authorizes FDA to conduct 

research relating to health information. 

Section 1003(d)(2)(C) of the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) (21 U.S.C. 393(d)(2)(C)) authorizes 

FDA to conduct research relating to 

drugs and other FDA regulated products 

in carrying out the provisions of the 

FD&C Act. 

The Office of Prescription Drug 

Promotion’s (OPDP) mission is to 

protect the public health by helping to 

ensure that prescription drug promotion 

is truthful, balanced, and accurately 

communicated. OPDP’s research 

program provides scientific evidence to 

help ensure that our policies related to 

prescription drug promotion will have 

the greatest benefit to public health. 

Toward that end, we have consistently 

conducted research to evaluate the 

aspects of prescription drug promotion 

that are most central to our mission. Our 

research focuses in particular on three 

main topic areas: Advertising features, 

including content and format; target 

populations; and research quality. 

Through the evaluation of advertising 

features, we assess how elements such 

as graphics, format, and disease and 


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