Charter Renewal of the National Vaccine Advisory Committee, 39600 [2017-17527]

Download as PDF asabaliauskas on DSKBBXCHB2PROD with NOTICES 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 VerDate Sep<11>2014 18:37 Aug 18, 2017 Jkt 241001 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 National Vaccine Program Office, Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services. ACTION: Notice. AGENCY: 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 https://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 https://www.facadatabase.gov/. The Department of Health and Human Services is hereby giving notice that the charter for the National Vaccine Advisory Committee (NVAC) has been renewed. Dated: August 14, 2017. Melinda Wharton, Acting Director, National Vaccine Program Office. FOR FURTHER INFORMATION CONTACT: BILLING CODE 4150–44–P SUMMARY: 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. 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 SUPPLEMENTARY INFORMATION: PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 [FR Doc. 2017–17527 Filed 8–18–17; 8:45 am] 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. E:\FR\FM\21AUN1.SGM 21AUN1

Agencies

[Federal Register Volume 82, Number 160 (Monday, August 21, 2017)]
[Notices]
[Page 39600]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-17527]


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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.

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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 https://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 
https://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
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