39600 Federal Register / Vol. 82, No. 160 / Monday, August 21, 2017 / Notices 

material to patient or consumer 

audiences versus risk information that is 

material primarily to the prescriber or 

other health care providers? What data 

are available to answer this question? 

5. What criteria should be used to 

determine which risk information that is 

material to patient or consumer 

audiences to include in the major 

statement for DTC prescription drug 

broadcast advertisements to best protect 

the public health? What data are 

available to answer this question? 

6. What is the potential impact of 

including (or conversely, of not 

including), in the major statement for 

DTC prescription drug broadcast 

advertisements, additional language that 

states that there are other risks not 

included in the advertisement while 

simultaneously encouraging dialogue 

between patients and their health care 

providers? (For example, additional 

language could include, ‘‘This is not a 

full list of risks and side effects. Talk to 

your health care provider and read the 

patient labeling for more information.’’) 

What data are available to answer this 

question? 

7. What data are available on 

consumers’ comprehension of the 

difference between levels (i.e., severity) 

of risk? Would it be in the interest of 

public health to include a signal before 

the risk information that frames and 

categorizes the overall level of risk 

associated with the product? One 

approach may be to include an opening 

statement tailored to the risk profile of 

the drug. For example, drugs could be 

divided into three defined categories 

and include the corresponding opening 

statements: 

a. For drugs with severe, lifethreatening risks: ‘‘[Drug] can cause 

severe, life-threatening reactions. These 

include . . . .’’ 

b. For drugs with serious but not lifethreatening risks: ‘‘[Drug] can cause 

serious reactions. These include . . . .’’ 

c. For drugs with no severe or serious 

risks: ‘‘[Drug] can cause reactions. These 

include . . . .’’ 

8. Should potential food and drug 

interactions be disclosed in DTC 

prescription drug broadcast 

advertisements, and if so, what criteria 

should be used to identify these 

interactions? 

FDA will consider all information and 

comments submitted. 

III. References 

The following references are on 

display in the Dockets Management 

Staff office (see ADDRESSES) and are 

available for viewing by interested 

persons between 9 a.m. and 4 p.m., 

Monday through Friday; they are also 

available electronically at https://

www.regulations.gov. 

1. Delbaere, M. and M.C. Smith, ‘‘Health 

Care Knowledge and Consumer Learning: 

The Case of Direct-to-Consumer Drug 

Advertising,’’ Health Marketing Quarterly, 

vol. 23, issue 3, pp. 9–29, 2006. 

2. Friedman, M. and J. Gould, ‘‘Consumer 

Attitudes and Behaviors Associated With 

Direct-to-Consumer Prescription Drug 

Marketing,’’ Journal of Consumer Marketing, 

vol. 24, issue 2, pp. 100–109, 2007. 

3. Frosch, D.L., P.M. Krueger, R.C. Hornik, 

P.F. Cronholm, and F.K. Barg, ‘‘Creating 

Demand for Prescription Drugs: A Content 

Analysis of Television Direct-to-Consumer 

Advertising,’’ The Annals of Family 

Medicine, vol. 5, issue 1, pp. 6–13, 2007. 

Dated: August 15, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–17563 Filed 8–18–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Charter Renewal of the National 

Vaccine Advisory Committee 

AGENCY: National Vaccine Program 

Office, Office of the Assistant Secretary 

for Health, Office of the Secretary, 

Department of Health and Human 

Services. 

ACTION: Notice. 

SUMMARY: The Department of Health and 

Human Services is hereby giving notice 

that the charter for the National Vaccine 

Advisory Committee (NVAC) has been 

renewed. 

FOR FURTHER INFORMATION CONTACT: 

National Vaccine Program Office, U.S. 

Department of Health and Human 

Services, Room 715H, Hubert H. 

Humphrey Building, 200 Independence 

Avenue SW., Washington, DC 20201. 

Phone: (202) 690–5566; email: nvac@

hhs.gov. 

SUPPLEMENTARY INFORMATION: NVAC is a 

non-discretionary Federal advisory 

committee. The establishment of NVAC 

was mandated under Section 2105 (42 

U.S.C. Section 300aa–5) of the Public 

Health Service Act, as amended (PHS 

Act). The Committee is governed by 

provisions of the Federal Advisory 

Committee Act (FACA), Public Law 92– 

463, as amended (5 U.S.C. App.). NVAC 

advises and makes recommendations to 

the Director, National Vaccine Program 

(NVP), on matters related to the 

Program’s responsibilities. The 

Assistant Secretary for Health is 

appointed to serve as the Director, NVP. 

To carry out its mission, NVAC (1) 

studies and recommends ways to 

encourage the availability of an 

adequate supply of safe and effective 

vaccination products in the United 

States; (2) recommends research 

priorities and other measures the 

Director of the NVP should take to 

enhance the safety and efficacy of 

vaccines; (3) advises the Director of the 

NVP in the implementation of Sections 

2102 and 2103 of the PHS Act; and (4) 

identifies annually for the Director of 

the NVP the most important areas of 

governmental and non-governmental 

cooperation that should be considered 

in implementing Sections 2101 and 

2103 of the PHS Act. 

On July 21, 2017, the Acting Assistant 

Secretary for Health approved renewal 

of the NVAC charter with minor 

amendments. The new charter was 

effected and filed with the appropriate 

Congressional committees and Library 

of Congress on July 30, 2017. Renewal 

of the NVAC charter gives authorization 

for the Committee to continue to operate 

until July 30, 2019. 

A copy of the NVAC charter is 

available on the Web site for the 

National Vaccine Program Office at 

http://www.hhs.gov/nvpo/nvac. A copy 

of the charter also can be obtained by 

accessing the FACA database that is 

maintained by the Committee 

Management Secretariat under the 

General Services Administration. The 

Web site address for the FACA database 

is http://www.facadatabase.gov/. 

Dated: August 14, 2017. 

Melinda Wharton, 

Acting Director, National Vaccine Program 

Office. 

[FR Doc. 2017–17527 Filed 8–18–17; 8:45 am] 

BILLING CODE 4150–44–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

Division of Behavioral Health; Office of 

Clinical and Preventive Services; Zero 

Suicide Initiative—Support 

Announcement Type: New. 

Funding Announcement Number: 

HHS–2018–IHS–ZSI–0001. 

Catalog of Federal Domestic 

Assistance Number: 93.933. 

Key Dates 

Application Deadline Date: October 

12, 2017. 

Review Date: October 16–20, 2017. 

Earliest Anticipated Start Date: 

November 1, 2017. 

Signed Tribal Resolution Due Date: 

October 12, 2017. 

Proof of Non-Profit Status Due Date: 

October 12, 2017. 


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