Federal Register / Vol. 83, No. 154 / Thursday, August 9, 2018 / Notices 39441 

1The Federal Trade Commission (FTC), which 

regulates the advertising of non-prescription drug 

products as well as other non-FDA regulated 

products (e.g., package goods, cars, etc.) issued a 

specific position on disclosures (Ref. 5) for the 

advertising it regulates. Specifically, FTC explains 

that disclosures must be ‘‘clear and conspicuous’’; 

in other words, in understandable language, located 

near the claim to be further clarified, and not 

hidden or minimized by small font or other 

distractions. 

meetings and other committee 

management activities, for both the 

Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Sherri A. Berger, 

Chief Operating Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. 2018–17042 Filed 8–8–18; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Notice of Closed Meeting 

In accordance with Section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), the Centers for Disease 

Control and Prevention (CDC) 

announces the following meeting. 

The meeting will be closed to the 

public in accordance with provisions set 

forth in Section 552b(c) (4) and (6), Title 

5 U.S.C., and the Determination of the 

Director, Management Analysis and 

Services Office, CDC, pursuant to Public 

Law 92–463. 

Name of Committee: Safety and 

Occupational Health Study Section 

(SOHSS), National Institute for 

Occupational Safety and Health 

(NIOSH). 

Dates: October 16–October 18, 2018. 

Time: 8:00 a.m.–5:00 p.m., EDT. 

Place: Embassy Suites, 1900 Diagonal 

Road, Alexandria, VA 22314. 

Agenda: The meeting will convene to 

address matters related to the conduct of 

Study Section business and for the 

study section to consider safety and 

occupational health-related grant 

applications. 

For Further Information Contact: Nina 

Turner, Ph.D., Scientific Review Officer, 

NIOSH, 1095 Willowdale Road, 

Morgantown, WV 26506, (304) 285– 

5976; nturner@cdc.gov. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities, for both the 

Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Sherri Berger, 

Chief Operating Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. 2018–17043 Filed 8–8–18; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–0558] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Disclosures in 

Professional and Consumer 

Prescription Drug Promotion 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) 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 

(PRA). 

DATES: Fax written comments on the 

collection of information by September 

10, 2018. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, Fax: 202– 

395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–NEW and 

title ‘‘Disclosures in Professional and 

Consumer Prescription Drug 

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. 

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. 

Disclosures in Professional and 

Consumer Prescription Drug 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. 

FDA regulates prescription drug 

advertising and promotional labeling 

directed to healthcare professionals 

(HCPs) and consumers (section 502(a) 

and (n), respectively, of the FD&C Act 

(21 U.S.C. 352(a) and (n))). In the course 

of promoting their products, 

pharmaceutical sponsors (sponsors) may 

present a variety of information 

including the indication, details about 

the administration of the product, 

efficacy information, and clinical trial 

data. To present often complicated 

information concisely, sponsors may not 

include relevant information in the 

body of the text or visual display of the 

claim. Additionally, sponsors may not 

always present limitations to the claim 

in the main body of the text or display. 

In these cases, sponsors typically 

include disclosures of information 

somewhere in the promotional piece. 

There is limited published research 

on disclosures in prescription drug 

promotion, either directed to consumers 

or to HCPs. The use of disclosures is one 

method of communicating information 

to HCPs and consumers about scientific 

and clinical data, the limitations of that 

data, and practical utility of that 

information. These disclosures may 

influence HCP and consumer 

comprehension and decision making, 

and may affect how and what treatment 

HCPs prescribe for their patients. 

Previous research on the effectiveness of 

disclosures has been conducted 

primarily in the dietary supplement 

arena (Refs. 1–4). Thus, the proposed 

research will examine the effectiveness 

of clear and conspicuous disclosures in 

prescription drug promotion directed to 

both populations. The purpose of our 

study is to determine how useful 

disclosures regarding prescription drug 

information are when presented 

prominently and adjacent to claims.1

Specifically, are HCPs and consumers 

able to use disclosures to effectively 

frame information in efficacy claims in 

prescription drug promotion? 

To address this research question, we 

have designed a set of studies that cover 

both consumers and HCPs, as well as 

three presentations addressing different 


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