Federal Register / Vol. 80, No. 65 / Monday, April 6, 2015 / Notices 18407 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Dental & 

Craniofacial Research; Notice of 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of a meeting of the Board 

of Scientific Counselors, National 

Institute of Dental and Craniofacial 

Research. 

The meeting will be closed to the 

public as indicated below in accordance 

with the provisions set forth in section 

552b(c)(6), title 5 U.S.C., as amended for 

the review, discussion, and evaluation 

of individual intramural programs and 

projects conducted by the National 

Institute of Dental & Craniofacial 

Research, including consideration of 

personnel qualifications and 

performance, and the competence of 

individual investigators, the disclosure 

of which would constitute a clearly 

unwarranted invasion of personal 

privacy. 

Name of Committee: Board of Scientific 

Counselors, National Institute of Dental and 

Craniofacial Research. 

Date: May 28–29, 2015. 

Time: May 28, 2015, 12:00 p.m. to 5:40 

p.m. 

Agenda: To review and evaluate personal 

qualifications and performance, and 

competence of individual investigators. 

Place: National Institutes of Health, 

Building 30, Room 117, NIH Campus, 

Bethesda, MD 20892. 

Time: May 29, 2015, 8:00 a.m. to 

Adjournment. 

Agenda: To review and evaluate personal 

qualifications and performance, and 

competence of individual investigators. 

Place: National Institutes of Health, 

Building 30, Room 117, NIH Campus, 

Bethesda, MD 20892 

Contact Person: Alicia J. Dombroski, Ph.D., 

Director, Division of Extramural Activities, 

Natl Inst of Dental and Craniofacial Research, 

National Institutes of Health, Bethesda, MD 

20892, (301) 594–4805. 

Information is also available on the 

Institute’s/Center’s home page: http://

www.nidcr.nih.gov/about/

CouncilCommittees.asp, where an agenda 

and any additional information for the 

meeting will be posted when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.121, Oral Diseases and 

Disorders Research, National Institutes of 

Health, HHS) 

Dated: March 31, 2015. 

David Clary, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2015–07738 Filed 4–3–15; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–0554] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Comparative Price 

Information in Direct-to-Consumer and 

Professional Prescription Drug 

Advertisements 

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. 

DATES: Fax written comments on the 

collection of information by May 6, 

2015. 

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, ‘‘Comparative Price Information in 

Direct-to-Consumer and Professional 

Prescription Drug Advertisements.’’ 

Also include the FDA docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, 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. 

Comparative Price Information in 

Direct-to-Consumer and Professional 

Prescription Drug Advertisements— 

(0910–NEW) 

Section 1701(a)(4) of the Public 

Health Service Act (42 U.S.C. 

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

conduct research relating to health 

information. Section 1003(d)(2)(C) of the 

Federal Food, Drug, and Cosmetic Act 

(the 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. 

By their very nature, medical and 

health decisions are comparative (e.g., 

treat versus not treat). For consumers, 

these decisions may include the use of 

prescription drug products versus over 

the counter products versus herbal 

supplements, as well as one 

prescription brand versus another 

prescription brand. Similarly, 

advertising is often comparative. In 

prescription drug advertising, sponsors 

are permitted to include truthful, nonmisleading information about the price 

of their products in promotion. This 

may extend to price comparison 

information, wherein sponsors may 

include information about the price of a 

competing product in order to make 

advantageous claims. Currently, when 

price comparisons are made, the 

advertisement (ad) should also include 

context that the two drugs may not be 

comparable in terms of efficacy and 

safety and that the acquisition costs 

presented do not necessarily reflect the 

actual prices paid by consumers, 

pharmacies, or third party payers. 

Despite the inclusion of this additional 

information, there is concern that 

adding contextual information about 

efficacy or safety is not sufficient to 

correct the impression that the products 

are interchangeable and that price is the 

main factor to consider. The Office of 

Prescription Drug Promotion plans to 

investigate, through empirical research, 

the impact of price comparison 

information and additional contextual 

information on prescription drug 

product perceptions. This will be 

investigated in direct-to-consumer 

(DTC) and healthcare-directed 

professional advertising for prescription 

drugs. 

Design Overview and Procedure 

The design consists of two pretests 

and a main study. We will conduct two 

sequential pretest waves prior to main 

data collection. The purpose the pretests 

are to: (1) Ensure the stimuli are 

understandable and viewable; (2) 

identify and address any challenges to 

embedding the stimuli within the online 

survey; and (3) ensure the study 

questions are appropriate and meet the 

study’s goals. Participants in the 

pretests will be randomly assigned to 

one of two versions of an ad. One 

version will present information about 

the price of the product relative to a 

competitor for the same indication 

(Price Comparison). Another version 

will present this information with 

additional contextual information that 

the two drugs may not be comparable in 


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