80_FR_11482 80 FR 11441 - Advisory Committee on Immunization Practices (ACIP)

80 FR 11441 - Advisory Committee on Immunization Practices (ACIP)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 80, Issue 41 (March 3, 2015)

Page Range11441-11442
FR Document2015-04330

Federal Register, Volume 80 Issue 41 (Tuesday, March 3, 2015)
[Federal Register Volume 80, Number 41 (Tuesday, March 3, 2015)]
[Notices]
[Pages 11441-11442]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-04330]


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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: http://www.cdc.gov/vaccines/acip/index.html.
    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 [email protected].
    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



                                                                                  Federal Register / Vol. 80, No. 41 / Tuesday, March 3, 2015 / Notices                                                   11441

                                                  as compared to an examination by a                      evidence of consumers’ actual                           other matters of special interest to HHS
                                                  dermatologist.10                                        interpretations, and thus requires a very               regarding current and future chemical,
                                                     Thus, the orders impose a high level                 high level of substantiation for health-                biological, nuclear, and radiological
                                                  of substantiation despite lacking                       related apps, we are likely to chill                    agents, whether naturally occurring,
                                                  evidence that the marketing claims                      innovation in such apps, limit the                      accidental, or deliberate. The NPRSB
                                                  require such substantiation, and the                    potential benefits of this innovation,                  may also provide advice and guidance
                                                  complaints’ vague claim construction                    and ultimately make consumers worse                     to the Secretary and/or the Assistant
                                                  obscures this flawed approach.11                        off.13                                                  Secretary for Preparedness and
                                                  Despite the assurances in the majority’s                  I therefore respectfully dissent.                     Response (ASPR) on other matters
                                                  statement as to what the orders require,                [FR Doc. 2015–04348 Filed 3–2–15; 8:45 am]              related to public health emergency
                                                  the complaints imply—and the majority                   BILLING CODE 6750–01–P                                  preparedness and response.
                                                  appears to agree 12—that reasonable                                                                                Background: This public meeting via
                                                  consumers expected the apps to                                                                                  teleconference will be dedicated to the
                                                  substitute for professional medical care.               DEPARTMENT OF HEALTH AND                                NPRSB’s deliberation and vote on the
                                                  This disconnect raises the possibility                  HUMAN SERVICES                                          findings from the ASPR Future
                                                  that the Commission may use vague                                                                               Strategies Working Group. Subsequent
                                                  complaints to impose very high                          Meeting of the National Preparedness                    agenda topics will be added as priorities
                                                  substantiation standards on health-                     and Response Science Board                              dictate. Any additional agenda topics
                                                  related apps even if the advertising                                                                            will be available on the NPRSB March
                                                  claims for those apps are more modest.                  AGENCY:  Office of the Secretary,
                                                                                                                                                                  30, 2015, meeting Web page, available at
                                                     This approach concerns me. Health-                   Department of Health and Human
                                                                                                                                                                  WWW.PHE.GOV/NPRSB.
                                                  related apps have enormous potential to                 Services.
                                                                                                          ACTION: Notice.
                                                                                                                                                                     Availability of Materials: The meeting
                                                  improve access to health information for                                                                        agenda and materials will be posted
                                                  underserved populations and to enable                                                                           prior to the meeting on the March 30th
                                                                                                          SUMMARY:   As stipulated by the Federal
                                                  individuals to monitor more effectively                                                                         meeting Web page at WWW.PHE.GOV/
                                                                                                          Advisory Committee Act, the
                                                  their own well-being, thereby improving                                                                         NPRSB.
                                                                                                          Department of Health and Human
                                                  health outcomes. Health-related apps
                                                                                                          Services (HHS) is hereby giving notice                     Procedures for Providing Public Input:
                                                  need not be as accurate as professional
                                                                                                          that the National Preparedness and                      Members of the public are invited to
                                                  care to provide significant value for
                                                                                                          Response Science Board (NPRSB), also                    attend by teleconference via a toll-free
                                                  many consumers. The Commission
                                                                                                          known as the National Biodefense                        call-in phone number which is available
                                                  should not subject such apps to overly
                                                                                                          Science Board, will be holding a public                 on the NPRSB Web site at
                                                  stringent substantiation requirements,
                                                                                                          teleconference.                                         WWW.PHE.GOV/NPRSB. All members
                                                  so long as developers adequately convey
                                                  the limitations of their products. In                   DATES: The NPRSB will hold a public                     of the public are encouraged to provide
                                                  particular, the Commission should be                    meeting on March 30, 2015, from 1:00                    written comment to the NPRSB. All
                                                  very wary of concluding that consumers                  p.m. to 2:00 p.m. EST. The agenda is                    written comments must be received
                                                  interpret marketing for health-related                  subject to change as priorities dictate.                prior to March 29, 2015, and should be
                                                  apps as claiming that those apps                        ADDRESSES: Individuals who wish to                      sent by email to NPRSB@HHS.GOV with
                                                  substitute for professional medical care,               participate should send an email to                     ‘‘NPRSB Public Comment’’ as the
                                                  unless we can point to express claims,                  NPRSB@HHS.GOV with ‘‘NPRSB                              subject line. Public comments received
                                                  clearly implied claims, or extrinsic                    Registration’’ in the subject line. The                 by close of business one week prior to
                                                  evidence. If the Commission continues                   meeting will occur by teleconference.                   each teleconference will be distributed
                                                  to adopt such conclusions without any                   To attend via teleconference and for                    to the NPRSB in advance.
                                                                                                          further instructions, please visit the                    Dated: February 24, 2015.
                                                    10 When    the FTC cannot ‘‘conclude with             NPRSB Web site at WWW.PHE.GOV/                          Nicole Lurie,
                                                  confidence’’ that a specific implied claim is being     NPRSB.                                                  Assistant Secretary for Preparedness and
                                                  made—for example, if the ad contains ‘‘conflicting
                                                  messages’’—the FTC ‘‘will not find the ad to make       FOR FURTHER INFORMATION CONTACT:                        Response.
                                                  the implied claim unless extrinsic evidence allows      Please submit an inquiry via the NPRSB                  [FR Doc. 2015–04303 Filed 3–2–15; 8:45 am]
                                                  us to conclude that such a reading of the ad is         Contact Form located at www.phe.gov/                    BILLING CODE P
                                                  reasonable.’’ In re Thompson Med. Co., 104 F.T.C.       NBSBComments.
                                                  648, 788–89 (1984).
                                                     11 These onerous substantiation requirements         SUPPLEMENTARY INFORMATION: Pursuant
                                                  cannot be defended as ‘‘fencing-in.’’ The FTC does      to section 319M of the Public Health                    DEPARTMENT OF HEALTH AND
                                                  not traditionally fence in companies by requiring a
                                                                                                          Service Act (42 U.S.C. 247d–7f) and                     HUMAN SERVICES
                                                  heightened level of substantiation. Instead, past
                                                  FTC decisions fence in companies by extending the       section 222 of the Public Health Service                Centers for Disease Control and
                                                  scope of a substantiation requirement beyond the        Act (42 U.S.C. 217a), HHS established                   Prevention
                                                  specific product, parties, or type of conduct           the NPRSB. The Board shall provide
                                                  involved in the actual violation. See Federal Trade
                                                  Commission v. Springtech 77376, LLC, et al.
                                                                                                          expert advice and guidance to the                       Advisory Committee on Immunization
                                                  (‘‘Cedarcide Industries’’), Matter No. X120042,         Secretary on scientific, technical, and                 Practices (ACIP)
                                                  Dissenting Statement of Commissioner Maureen K.
                                                  Ohlhausen at 3 (July 16, 2013). Requiring past             13 See, e.g., Scott Gottlieb and Coleen Klasmeier,     Correction: This notice was published
                                                  violators to meet a higher burden of substantiation     ‘‘Why Your Phone Isn’t as Smart as It Could Be,’’
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                                                                                                                                                                  in the Federal Register on January 30,
                                                  would not fence them in—it would only make it           Wall Street Journal (Aug. 7, 2014) (blaming heavy
                                                  more difficult for them to make truthful claims that    regulation of consumer-directed health apps and
                                                                                                                                                                  2015, Volume 80, Number 20, Page
                                                  could be useful to consumers. Id.                       devices for smartphones that are ‘‘purposely            5116–5117. Due to inclement weather in
                                                     12 ‘‘Commissioner Ohlhausen . . . believes . . .     dumbed down’’ and ‘‘products that are never             the Atlanta, Georgia area, the first day
                                                  that it is not reasonable to read the ads as claiming   created because mobile-tech entrepreneurs choose        of the meeting scheduled for February
                                                  that the automated assessment is as accurate as a       to direct their talents elsewhere’’), available at
                                                  dermatologist. We disagree.’’ Statement of              http://online.wsj.com/articles/scott-gottlieb-and-
                                                                                                                                                                  25 and 26, 2015 was not held. The
                                                  Chairwoman Ramirez, Commissioner Brill, and             coleen-klasmeier-why-your-phone-isnt-as-smart-as-       second day of the meeting will take
                                                  Commissioner McSweeny at 1.                             it-could-be-1407369163.                                 place as follows:


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                                                  11442                                Federal Register / Vol. 80, No. 41 / Tuesday, March 3, 2015 / Notices

                                                     Times and Dates: 10:00 a.m.–2:00                               Prevention and the Agency for Toxic                       and policies. Applications are reviewed
                                                  p.m., February 26, 2015.                                          Substances and Disease Registry.                          by subject experts knowledgeable in
                                                     The meeting will be webcast live via                                                                                     child welfare and related fields. Review
                                                                                                                    Catherine Ramadei,
                                                  the World Wide Web; for instructions                                                                                        findings are advisory to CB; CB is
                                                                                                                    Acting Director, Management Analysis and                  responsible for making award decisions.
                                                  and more information on ACIP please                               Services Office, Centers for Disease Control
                                                                                                                    and Prevention.
                                                                                                                                                                                 This announcement is a request for
                                                  visit the ACIP Web site: http://
                                                                                                                                                                              approval of the proposed information
                                                  www.cdc.gov/vaccines/acip/index.html.                             [FR Doc. 2015–04330 Filed 3–2–15; 8:45 am]
                                                                                                                                                                              collection system, the Reviewer
                                                     Matters To Be Discussed: The                                   BILLING CODE 4163–18–P
                                                                                                                                                                              Recruitment Module (RRM). CB will use
                                                  shortened agenda will include                                                                                               a web-based data collection form and
                                                  discussions and votes on: Influenza                                                                                         database to gather critical reviewer
                                                                                                                    DEPARTMENT OF HEALTH AND
                                                  LAIV use, serogroup B meningococcal                                                                                         information in drop down menu format
                                                                                                                    HUMAN SERVICES
                                                  (MenB) vaccines use in high risk groups,                                                                                    for data such as: degree, occupation,
                                                  including outbreaks, and the use of                               Administration for Children and                           affiliations with organizations and
                                                  9vHPV vaccine.                                                    Families                                                  institutions that serve special
                                                     Agenda items are subject to change as                                                                                    populations, and demographic
                                                  priorities dictate.                                               Submission for OMB Review;                                information that may be voluntarily
                                                                                                                    Comment Request                                           provided by a potential reviewer.
                                                     Contact Person for More Information:                                                                                        These data elements will help CB find
                                                  Stephanie B. Thomas, National Center                                 Title: Grant Reviewer Recruitment                      and select expert grant reviewers for
                                                  for Immunization and Respiratory                                  Form.                                                     objective review committees. The web-
                                                  Diseases, CDC, 1600 Clifton Road NE.,                                OMB No.: NEW.                                          based system will permit reviewers to
                                                  MS–A27, Atlanta, Georgia 30333,                                      Description: The Administration for                    access and update their information at
                                                  telephone: (404) 639–8836; Email                                  Children and Families’ Children’s                         will and as needed. The RRM will be
                                                  ACIP@CDC.GOV.                                                     Bureau (CB) is responsible for                            accessible by the general public via
                                                     The Director, Management Analysis                              administering the review of eligible                      https://rrm.grantsolutions.gov/
                                                  and Services Office, has been delegated                           grant applications submitted in                           AgencyPortal/cb.aspx.
                                                  the authority to sign Federal Register                            response to funding opportunity                              Respondents: Generally, our
                                                                                                                    announcements issued by CB. CB                            reviewers are current or retired
                                                  notices pertaining to announcements of
                                                                                                                    ensures that the objective review                         professionals with backgrounds in child
                                                  meetings and other committee
                                                                                                                    process is independent, efficient,                        welfare and related fields and in some
                                                  management activities for both the
                                                                                                                    effective, economical, and complies                       instances current or former foster care
                                                  Centers for Disease Control and                                   with the applicable statutes, regulations,                parents or clients.

                                                                                                                            ANNUAL BURDEN ESTIMATES
                                                                                                                                                                              Number of           Average
                                                                                                                                                            Number of                                          Total burden
                                                                                             Instrument                                                                     responses per       burden hours
                                                                                                                                                           respondents                                            hours
                                                                                                                                                                              respondent        per response

                                                  Reviewer recruitment module ..........................................................................         500              1                 .25            125



                                                   Estimated Total Annual Burden                                    directly to the following: Office of                         Description: The Office of Refugee
                                                  Hours: 125.                                                       Management and Budget, Paperwork                          Resettlement (ORR) reimburses, to the
                                                                                                                    Reduction Project, Email: OIRA_                           extent of available appropriations,
                                                  Additional Information
                                                                                                                    SUBMISSION@OMB.EOP.GOV, Attn:                             certain non-federal costs for the
                                                    Copies of the proposed collection may                           Desk Officer for the Administration for                   provision of cash and medical
                                                  be obtained by writing to the                                     Children and Families.                                    assistance to refugees, along with
                                                  Administration for Children and                                                                                             allowable expenses for the
                                                                                                                    Robert Sargis,
                                                  Families, Office of Planning, Research                                                                                      administration of the refugee
                                                  and Evaluation, 370 L’Enfant                                      Reports Clearance Officer.                                resettlement program at the State level.
                                                  Promenade SW., Washington, DC 20447,                              [FR Doc. 2015–04320 Filed 3–2–15; 8:45 am]                States (and Wilson/Fish projects; i.e.,
                                                  Attn: ACF Reports Clearance Officer. All                          BILLING CODE 4184–01–P                                    alternative projects for the
                                                  requests should be identified by the title                                                                                  administration of the refugee
                                                  of the information collection. Email                                                                                        resettlement program) currently submit
                                                  address: infocollection@acf.hhs.gov.                              DEPARTMENT OF HEALTH AND                                  the ORR–2 Quarterly Report on
                                                                                                                    HUMAN SERVICES                                            Expenditures and Obligations, which
                                                  OMB Comment                                                                                                                 provides aggregate expenditure and
                                                     OMB is required to make a decision                             Administration for Children and                           obligation data. This proposed data
                                                  concerning the collection of information                          Families                                                  collection collects expenditures and
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                                                  between 30 and 60 days after                                      Proposed Information Collection                           obligations data separately for each of
                                                  publication of this document in the                               Activity; Comment Request                                 the four CMA program components:
                                                  Federal Register. Therefore, a comment                                                                                      Refugee cash assistance, refugee medical
                                                  is best assured of having its full effect                         Proposed Projects                                         assistance, cash and medical assistance
                                                  if OMB receives it within 30 days of                                                                                        administration, and services for
                                                  publication. Written comments and                                   Title: ORR–2 Quarterly Report on                        unaccompanied minors. This
                                                  recommendations for the proposed                                  Expenditures and Obligations.                             breakdown of financial status data
                                                  information collection should be sent                               OMB No.: 0970–0407.                                     allows ORR to track program


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Document Created: 2015-12-18 11:55:41
Document Modified: 2015-12-18 11:55:41
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
Dates10:00 a.m.-2:00 p.m., February 26, 2015.
FR Citation80 FR 11441 

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