Advisory Committee on Immunization Practices (ACIP), 11441-11442 [2015-04330]

Download as PDF Federal Register / Vol. 80, No. 41 / Tuesday, March 3, 2015 / Notices as compared to an examination by a dermatologist.10 Thus, the orders impose a high level of substantiation despite lacking evidence that the marketing claims require such substantiation, and the complaints’ vague claim construction obscures this flawed approach.11 Despite the assurances in the majority’s statement as to what the orders require, the complaints imply—and the majority appears to agree 12—that reasonable consumers expected the apps to substitute for professional medical care. This disconnect raises the possibility that the Commission may use vague complaints to impose very high substantiation standards on healthrelated apps even if the advertising claims for those apps are more modest. This approach concerns me. Healthrelated apps have enormous potential to improve access to health information for underserved populations and to enable individuals to monitor more effectively their own well-being, thereby improving health outcomes. Health-related apps need not be as accurate as professional care to provide significant value for many consumers. The Commission should not subject such apps to overly stringent substantiation requirements, so long as developers adequately convey the limitations of their products. In particular, the Commission should be very wary of concluding that consumers interpret marketing for health-related apps as claiming that those apps substitute for professional medical care, unless we can point to express claims, clearly implied claims, or extrinsic evidence. If the Commission continues to adopt such conclusions without any mstockstill on DSK4VPTVN1PROD with NOTICES 10 When the FTC cannot ‘‘conclude with confidence’’ that a specific implied claim is being made—for example, if the ad contains ‘‘conflicting messages’’—the FTC ‘‘will not find the ad to make the implied claim unless extrinsic evidence allows us to conclude that such a reading of the ad is reasonable.’’ In re Thompson Med. Co., 104 F.T.C. 648, 788–89 (1984). 11 These onerous substantiation requirements cannot be defended as ‘‘fencing-in.’’ The FTC does not traditionally fence in companies by requiring a heightened level of substantiation. Instead, past FTC decisions fence in companies by extending the scope of a substantiation requirement beyond the specific product, parties, or type of conduct involved in the actual violation. See Federal Trade Commission v. Springtech 77376, LLC, et al. (‘‘Cedarcide Industries’’), Matter No. X120042, Dissenting Statement of Commissioner Maureen K. Ohlhausen at 3 (July 16, 2013). Requiring past violators to meet a higher burden of substantiation would not fence them in—it would only make it more difficult for them to make truthful claims that could be useful to consumers. Id. 12 ‘‘Commissioner Ohlhausen . . . believes . . . that it is not reasonable to read the ads as claiming that the automated assessment is as accurate as a dermatologist. We disagree.’’ Statement of Chairwoman Ramirez, Commissioner Brill, and Commissioner McSweeny at 1. VerDate Sep<11>2014 19:24 Mar 02, 2015 Jkt 235001 evidence of consumers’ actual interpretations, and thus requires a very high level of substantiation for healthrelated apps, we are likely to chill innovation in such apps, limit the potential benefits of this innovation, and ultimately make consumers worse off.13 I therefore respectfully dissent. [FR Doc. 2015–04348 Filed 3–2–15; 8:45 am] BILLING CODE 6750–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the National Preparedness and Response Science Board Office of the Secretary, Department of Health and Human Services. ACTION: Notice. AGENCY: As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Preparedness and Response Science Board (NPRSB), also known as the National Biodefense Science Board, will be holding a public teleconference. DATES: The NPRSB will hold a public meeting on March 30, 2015, from 1:00 p.m. to 2:00 p.m. EST. The agenda is subject to change as priorities dictate. ADDRESSES: Individuals who wish to participate should send an email to NPRSB@HHS.GOV with ‘‘NPRSB Registration’’ in the subject line. The meeting will occur by teleconference. To attend via teleconference and for further instructions, please visit the NPRSB Web site at WWW.PHE.GOV/ NPRSB. FOR FURTHER INFORMATION CONTACT: Please submit an inquiry via the NPRSB Contact Form located at www.phe.gov/ NBSBComments. SUPPLEMENTARY INFORMATION: Pursuant to section 319M of the Public Health Service Act (42 U.S.C. 247d–7f) and section 222 of the Public Health Service Act (42 U.S.C. 217a), HHS established the NPRSB. The Board shall provide expert advice and guidance to the Secretary on scientific, technical, and SUMMARY: 13 See, e.g., Scott Gottlieb and Coleen Klasmeier, ‘‘Why Your Phone Isn’t as Smart as It Could Be,’’ Wall Street Journal (Aug. 7, 2014) (blaming heavy regulation of consumer-directed health apps and devices for smartphones that are ‘‘purposely dumbed down’’ and ‘‘products that are never created because mobile-tech entrepreneurs choose to direct their talents elsewhere’’), available at https://online.wsj.com/articles/scott-gottlieb-andcoleen-klasmeier-why-your-phone-isnt-as-smart-asit-could-be-1407369163. PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 11441 other matters of special interest to HHS regarding current and future chemical, biological, nuclear, and radiological agents, whether naturally occurring, accidental, or deliberate. The NPRSB may also provide advice and guidance to the Secretary and/or the Assistant Secretary for Preparedness and Response (ASPR) on other matters related to public health emergency preparedness and response. Background: This public meeting via teleconference will be dedicated to the NPRSB’s deliberation and vote on the findings from the ASPR Future Strategies Working Group. Subsequent agenda topics will be added as priorities dictate. Any additional agenda topics will be available on the NPRSB March 30, 2015, meeting Web page, available at WWW.PHE.GOV/NPRSB. Availability of Materials: The meeting agenda and materials will be posted prior to the meeting on the March 30th meeting Web page at WWW.PHE.GOV/ NPRSB. Procedures for Providing Public Input: Members of the public are invited to attend by teleconference via a toll-free call-in phone number which is available on the NPRSB Web site at WWW.PHE.GOV/NPRSB. All members of the public are encouraged to provide written comment to the NPRSB. All written comments must be received prior to March 29, 2015, and should be sent by email to NPRSB@HHS.GOV with ‘‘NPRSB Public Comment’’ as the subject line. Public comments received by close of business one week prior to each teleconference will be distributed to the NPRSB in advance. Dated: February 24, 2015. Nicole Lurie, Assistant Secretary for Preparedness and Response. [FR Doc. 2015–04303 Filed 3–2–15; 8:45 am] BILLING CODE P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Advisory Committee on Immunization Practices (ACIP) Correction: This notice was published in the Federal Register on January 30, 2015, Volume 80, Number 20, Page 5116–5117. Due to inclement weather in the Atlanta, Georgia area, the first day of the meeting scheduled for February 25 and 26, 2015 was not held. The second day of the meeting will take place as follows: E:\FR\FM\03MRN1.SGM 03MRN1 11442 Federal Register / Vol. 80, No. 41 / Tuesday, March 3, 2015 / Notices Times and Dates: 10:00 a.m.–2:00 p.m., February 26, 2015. The meeting will be webcast live via the World Wide Web; for instructions and more information on ACIP please visit the ACIP Web site: https:// www.cdc.gov/vaccines/acip/. Matters To Be Discussed: The shortened agenda will include discussions and votes on: Influenza LAIV use, serogroup B meningococcal (MenB) vaccines use in high risk groups, including outbreaks, and the use of 9vHPV vaccine. Agenda items are subject to change as priorities dictate. Contact Person for More Information: Stephanie B. Thomas, National Center for Immunization and Respiratory Diseases, CDC, 1600 Clifton Road NE., MS–A27, Atlanta, Georgia 30333, telephone: (404) 639–8836; Email ACIP@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. Catherine Ramadei, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. 2015–04330 Filed 3–2–15; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Submission for OMB Review; Comment Request Title: Grant Reviewer Recruitment Form. OMB No.: NEW. Description: The Administration for Children and Families’ Children’s Bureau (CB) is responsible for administering the review of eligible grant applications submitted in response to funding opportunity announcements issued by CB. CB ensures that the objective review process is independent, efficient, effective, economical, and complies with the applicable statutes, regulations, and policies. Applications are reviewed by subject experts knowledgeable in child welfare and related fields. Review findings are advisory to CB; CB is responsible for making award decisions. This announcement is a request for approval of the proposed information collection system, the Reviewer Recruitment Module (RRM). CB will use a web-based data collection form and database to gather critical reviewer information in drop down menu format for data such as: degree, occupation, affiliations with organizations and institutions that serve special populations, and demographic information that may be voluntarily provided by a potential reviewer. These data elements will help CB find and select expert grant reviewers for objective review committees. The webbased system will permit reviewers to access and update their information at will and as needed. The RRM will be accessible by the general public via https://rrm.grantsolutions.gov/ AgencyPortal/cb.aspx. Respondents: Generally, our reviewers are current or retired professionals with backgrounds in child welfare and related fields and in some instances current or former foster care parents or clients. ANNUAL BURDEN ESTIMATES Instrument Number of respondents Number of responses per respondent Average burden hours per response Total burden hours Reviewer recruitment module .......................................................................... 500 1 .25 125 Estimated Total Annual Burden Hours: 125. Additional Information Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 370 L’Enfant Promenade SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. All requests should be identified by the title of the information collection. Email address: infocollection@acf.hhs.gov. mstockstill on DSK4VPTVN1PROD with NOTICES OMB Comment OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent VerDate Sep<11>2014 19:24 Mar 02, 2015 Jkt 235001 directly to the following: Office of Management and Budget, Paperwork Reduction Project, Email: OIRA_ SUBMISSION@OMB.EOP.GOV, Attn: Desk Officer for the Administration for Children and Families. Robert Sargis, Reports Clearance Officer. [FR Doc. 2015–04320 Filed 3–2–15; 8:45 am] BILLING CODE 4184–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Proposed Information Collection Activity; Comment Request Proposed Projects Title: ORR–2 Quarterly Report on Expenditures and Obligations. OMB No.: 0970–0407. PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 Description: The Office of Refugee Resettlement (ORR) reimburses, to the extent of available appropriations, certain non-federal costs for the provision of cash and medical assistance to refugees, along with allowable expenses for the administration of the refugee resettlement program at the State level. States (and Wilson/Fish projects; i.e., alternative projects for the administration of the refugee resettlement program) currently submit the ORR–2 Quarterly Report on Expenditures and Obligations, which provides aggregate expenditure and obligation data. This proposed data collection collects expenditures and obligations data separately for each of the four CMA program components: Refugee cash assistance, refugee medical assistance, cash and medical assistance administration, and services for unaccompanied minors. This breakdown of financial status data allows ORR to track program E:\FR\FM\03MRN1.SGM 03MRN1

Agencies

[Federal Register Volume 80, Number 41 (Tuesday, March 3, 2015)]
[Notices]
[Pages 11441-11442]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-04330]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Advisory Committee on Immunization Practices (ACIP)

    Correction: This notice was published in the Federal Register on 
January 30, 2015, Volume 80, Number 20, Page 5116-5117. Due to 
inclement weather in the Atlanta, Georgia area, the first day of the 
meeting scheduled for February 25 and 26, 2015 was not held. The second 
day of the meeting will take place as follows:

[[Page 11442]]

    Times and Dates: 10:00 a.m.-2:00 p.m., February 26, 2015.
    The meeting will be webcast live via the World Wide Web; for 
instructions and more information on ACIP please visit the ACIP Web 
site: https://www.cdc.gov/vaccines/acip/.
    Matters To Be Discussed: The shortened agenda will include 
discussions and votes on: Influenza LAIV use, serogroup B meningococcal 
(MenB) vaccines use in high risk groups, including outbreaks, and the 
use of 9vHPV vaccine.
    Agenda items are subject to change as priorities dictate.
    Contact Person for More Information: Stephanie B. Thomas, National 
Center for Immunization and Respiratory Diseases, CDC, 1600 Clifton 
Road NE., MS-A27, Atlanta, Georgia 30333, telephone: (404) 639-8836; 
Email ACIP@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.

Catherine Ramadei,
Acting Director, Management Analysis and Services Office, Centers for 
Disease Control and Prevention.
[FR Doc. 2015-04330 Filed 3-2-15; 8:45 am]
BILLING CODE 4163-18-P

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