81_FR_4318 81 FR 4302 - Request for Nominations of Candidates To Serve on the Advisory Committee on Immunization Practices (ACIP)

81 FR 4302 - Request for Nominations of Candidates To Serve on the Advisory Committee on Immunization Practices (ACIP)

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

Federal Register Volume 81, Issue 16 (January 26, 2016)

Page Range4302-4303
FR Document2016-01443

Federal Register, Volume 81 Issue 16 (Tuesday, January 26, 2016) 
[Federal Register Volume 81, Number 16 (Tuesday, January 26, 2016)]
[Notices]
[Pages 4302-4303]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-01443]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Request for Nominations of Candidates To Serve on the Advisory 
Committee on Immunization Practices (ACIP)

    The Centers for Disease Control and Prevention (CDC) is soliciting 
nominations for membership on ACIP. The ACIP consists of 15 experts in 
fields associated with immunization, who are selected by the Secretary 
of the U.S. Department of Health and Human Services (HHS) to provide 
advice and guidance to the Secretary, the Assistant Secretary for 
Health, and the CDC on the control of vaccine-preventable diseases. The 
role of the ACIP is to provide advice that will lead to a reduction in 
the incidence of vaccine preventable diseases in the United States, and 
an increase in the safe use of vaccines and related biological 
products. The committee also establishes, reviews, and as appropriate, 
revises the list of vaccines for administration to children eligible to 
receive vaccines through the Vaccines for Children (VFC) Program.
    Nominations are being sought for individuals who have expertise and 
qualifications necessary to contribute to the accomplishments of the 
committee's objectives. Nominees will be selected based on expertise in 
the field of immunization practices; multi-disciplinary expertise in 
public health; expertise in the use of vaccines and immunologic agents 
in both clinical and preventive medicine; knowledge of vaccine 
development, evaluation, and vaccine delivery; or knowledge about 
consumer perspectives and/or social and community aspects of 
immunization programs. Federal employees will not be considered for 
membership. Members may be invited to serve for four-year terms.
    The next cycle of selection of candidates will begin in the fall of 
2016,

[[Page 4303]]

for selection of potential nominees to replace members whose terms will 
end on June 30, 2017. Selection of members is based on candidates' 
qualifications to contribute to the accomplishment of ACIP objectives 
(http://www.cdc.gov/vaccines/acip/index.html). The U.S. Department of 
Health and Human Services policy stipulates that committee membership 
be balanced in terms of professional training and background, points of 
view represented, and the committee's function. Consideration is given 
to a broad representation of geographic areas within the U.S., with 
equitable representation of the sexes, ethnic and racial minorities, 
and persons with disabilities. Nominees must be U.S. citizens, and 
cannot be full-time employees of the U.S. Government. Candidates should 
submit the following items:
    [ssquf] Current curriculum vitae, including complete contact 
information (telephone numbers, mailing address, email address)
    [ssquf] At least one letter of recommendation from person(s) not 
employed by HHS *
    The deadline for receipt of all application materials (for 
consideration for term beginning July 1, 2017) is November 4, 2016. All 
files must be submitted electronically as email attachments to: Ms. 
Stephanie Thomas, ACIP Secretariat, Email: [email protected].
    Nominations may be submitted by the candidate him- or herself, or 
by the person/organization recommending the candidate.

    * Candidates may submit letter(s) from current HHS employees if 
they wish, but at least one letter must be submitted by a person not 
employed by HHS (e.g., CDC, NIH, FDA, etc.).

    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.

Elaine L. Baker,
Director, Management Analysis and Services Office, Centers for Disease 
Control and Prevention.
[FR Doc. 2016-01443 Filed 1-25-16; 8:45 am]
BILLING CODE 4163-18-P

4302 Federal Register / Vol. 81, No. 16 / Tuesday, January 26, 2016 / Notices major health agencies within HHS— logic, and reports. These specifications detailed agenda and logistical CDC, Centers for Medicare & Medicaid will ensure that data collected by PSOs information will be provided to Services, FDA, Health Resources and and other entities have comparable registrants. Prior to the meeting, AHRQ Services Administration, Indian Health clinical meaning. invites review of the technical Service, National Institutes of Health, The technical specifications also specifications for Common Formats National Library of Medicine, Office of provide direction to software which can be accessed through AHRQ’s the National Coordinator for Health developers, so that the Common PSO Web site at https://www.psoppc. Information Technology, Office of Formats can be implemented org/psoppc_web/publicpages/common Public Health and Science, and electronically, and to PSOs, so that the FormatsOverview. Substance Abuse and Mental Health Common Formats can be submitted Sharon B. Arnold, Services Administration—as well as the electronically to the Patient Safety AHRQ Deputy Director. DoD and VA. Organization Privacy Protection Center When developing Common Formats, (PSOPPC) for data de-identification and [FR Doc. 2016–01353 Filed 1–25–16; 8:45 am] AHRQ first reviews existing patient transmission to the NPSD. BILLING CODE 4160–90–P safety practices and event reporting Common Formats technical systems. In collaboration with the specifications consist of the following: PSWG and Federal subject matter • Data dictionary—defines data DEPARTMENT OF HEALTH AND experts, AHRQ drafts and releases beta elements and their attributes (data HUMAN SERVICES versions of the Common Formats for element name, answer values, field Centers for Disease Control and public review and comment. The PSWG length, guide for use, etc.) included in Prevention assists AHRQ with assuring the Common Formats; consistency of definitions/formats with • Clinical document architecture Request for Nominations of those of relevant government agencies (CDA) implementation guide—provides Candidates To Serve on the Advisory as refinement of the Common Formats instructions for developing a file to Committee on Immunization Practices continues. transmit the Common Formats Patient (ACIP) Since the initial release of the Safety data from the PSO to the PSOPPC Common Formats in August 2008, using the Common Formats; The Centers for Disease Control and AHRQ has regularly revised the formats • Validation rules and errors Prevention (CDC) is soliciting based upon public comment. AHRQ document—specifies and defines the nominations for membership on ACIP. solicits feedback on beta (and validation rules that will be applied to The ACIP consists of 15 experts in fields subsequent) versions of Common the Common Formats data elements associated with immunization, who are Formats from private sector submitted to the PSOPPC; selected by the Secretary of the U.S. organizations and individuals. Based • Common Formats flow charts— Department of Health and Human upon the feedback received, AHRQ diagrams the valid paths to complete Services (HHS) to provide advice and further revises the Common Formats. To generic and event specific formats (a guidance to the Secretary, the Assistant the extent practicable, the Common complete event report); Secretary for Health, and the CDC on the Formats are also aligned with World • Local specifications—provides control of vaccine-preventable diseases. Health Organization (WHO) concepts, specifications for processing, linking The role of the ACIP is to provide frameworks, and definitions. and reporting on events and details advice that will lead to a reduction in Participation by the private sector in specifications for reports; and the incidence of vaccine preventable the development and subsequent • Metadata registry—includes diseases in the United States, and an revision of the Common Formats is descriptive facts about information increase in the safe use of vaccines and achieved through working with the contained in the data dictionary to related biological products. The NQF. The Agency engages the NQF, a illustrate how such data corresponds committee also establishes, reviews, and non-profit organization focused on with similar data elements used by as appropriate, revises the list of health care quality, to solicit comments other Federal agencies and standards vaccines for administration to children and advice regarding proposed versions development organizations [e.g., HL—7, eligible to receive vaccines through the of the Common Formats. AHRQ began International Standards Organization Vaccines for Children (VFC) Program. this process with the NQF in 2008, (ISO)]. Nominations are being sought for receiving feedback on AHRQ’s 0.1 Beta individuals who have expertise and release of the Common Formats for Agenda, Registration, and Other qualifications necessary to contribute to Event Reporting—Hospital. After Information about the Meeting the accomplishments of the committee’s receiving public comment, the NQF The 2016 meeting will be an objectives. Nominees will be selected solicits the review and advice of its interactive forum designed to allow based on expertise in the field of Common Formats Expert Panel and meeting participants not only to provide immunization practices; multi- subsequently provides feedback to input but also to respond to the input disciplinary expertise in public health; AHRQ. The Agency then revises and provided by others. The meeting agenda expertise in the use of vaccines and refines the Common Formats and issues will include: an update of Federal immunologic agents in both clinical and them as a production version. AHRQ efforts related to the Common Formats, preventive medicine; knowledge of has continued to employ this process for including development of formats for vaccine development, evaluation, and all subsequent versions of the Common new settings; Common Formats software vaccine delivery; or knowledge about mstockstill on DSK4VPTVN1PROD with NOTICES Formats. products demonstrations; a discussion consumer perspectives and/or social The technical specifications promote of data integrity related to submission of and community aspects of standardization of collected patient patient safety adverse events; and a immunization programs. Federal safety event information by specifying question and answer session. employees will not be considered for rules for data collection and submission, AHRQ requests that interested membership. Members may be invited as well as by providing guidance for persons send an email to the PSOPPC at to serve for four-year terms. how and when to create data elements, support@psoppc.org for registration The next cycle of selection of their valid values, conditional and go-to information. Before the meeting, a candidates will begin in the fall of 2016, VerDate Sep<11>2014 21:57 Jan 25, 2016 Jkt 238001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 E:\FR\FM\26JAN1.SGM 26JAN1

Federal Register / Vol. 81, No. 16 / Tuesday, January 26, 2016 / Notices 4303 for selection of potential nominees to DEPARTMENT OF HEALTH AND exchanged information. This document replace members whose terms will end HUMAN SERVICES highlights considerations that should be on June 30, 2017. Selection of members included in the development and design is based on candidates’ qualifications to Centers for Disease Control and of interoperable medical devices and contribute to the accomplishment of Prevention provides recommendations for the ACIP objectives (http://www.cdc.gov/ content of premarket submissions and Board of Scientific Counselors, labeling for such devices. This draft vaccines/acip/index.html). The U.S. National Center for Health Statistics guidance is not final nor is it in effect Department of Health and Human (BSC, NCHS) Services policy stipulates that at this time. committee membership be balanced in Notice of Cancellation: This notice DATES: Although you can comment on terms of professional training and was published in the Federal Register any guidance at any time (see 21 CFR background, points of view represented, on December 23, 2015, Volume 80, 10.115(g)(5)), to ensure that the Agency Number 246, pages 79899–79900. The considers your comment of this draft and the committee’s function. meeting previously scheduled to guidance before it begins work on the Consideration is given to a broad convene on January 21–22, 2016, has final version of the guidance, submit representation of geographic areas either electronic or written comments within the U.S., with equitable been cancelled. Contact Person for More Information: on the draft guidance by March 28, representation of the sexes, ethnic and 2016. racial minorities, and persons with Virginia S. Cain, Ph.D., Director of Extramural Research, NCHS/CDC, 3311 ADDRESSES: You may submit comments disabilities. Nominees must be U.S. Toledo Road, Room 7208, Hyattsville, as follows: citizens, and cannot be full-time Maryland 20782, Telephone (301) 458– employees of the U.S. Government. Electronic Submissions 4395, Fax (301) 458–4020, Email: Candidates should submit the following vcain@cdc.gov. Submit electronic comments in the items: The Director, Management Analysis following way: D Current curriculum vitae, including and Services Office, has been delegated • Federal eRulemaking Portal: http:// complete contact information the authority to sign Federal Register www.regulations.gov. Follow the (telephone numbers, mailing address, notices pertaining to announcements of instructions for submitting comments. email address) meetings and other committee Comments submitted electronically, management activities for both the including attachments, to http:// D At least one letter of www.regulations.gov will be posted to Centers for Disease Control and recommendation from person(s) not the docket unchanged. Because your Prevention and the Agency for Toxic employed by HHS * comment will be made public, you are Substances and Disease Registry. The deadline for receipt of all solely responsible for ensuring that your application materials (for consideration Elaine L. Baker, comment does not include any for term beginning July 1, 2017) is Director, Management Analysis and Services confidential information that you or a Office, Centers for Disease Control and third party may not wish to be posted, November 4, 2016. All files must be Prevention. such as medical information, your or submitted electronically as email attachments to: Ms. Stephanie Thomas, [FR Doc. 2016–01442 Filed 1–25–16; 8:45 am] anyone else’s Social Security number, or BILLING CODE 4163–18–P confidential business information, such ACIP Secretariat, Email: SThomas5@ as a manufacturing process. Please note cdc.gov. that if you include your name, contact Nominations may be submitted by the DEPARTMENT OF HEALTH AND information, or other information that candidate him- or herself, or by the HUMAN SERVICES identifies you in the body of your person/organization recommending the comments, that information will be candidate. Food and Drug Administration posted on http://www.regulations.gov. * Candidates may submit letter(s) from [Docket No. FDA–2015–D–4852] • If you want to submit a comment current HHS employees if they wish, but at with confidential information that you least one letter must be submitted by a Design Considerations and Premarket do not wish to be made available to the person not employed by HHS (e.g., CDC, Submission Recommendations for public, submit the comment as a NIH, FDA, etc.). Interoperable Medical Devices; Draft written/paper submission and in the Guidance for Industry and Food and manner detailed (see ‘‘Written/Paper The Director, Management Analysis Drug Administration Staff; Availability Submissions’’ and ‘‘Instructions’’). and Services Office, has been delegated Written/Paper Submissions AGENCY: Food and Drug Administration, the authority to sign Federal Register HHS. Submit written/paper submissions as notices pertaining to announcements of ACTION: Notice of availability. follows: meetings and other committee • Mail/Hand delivery/Courier (for management activities for both the SUMMARY: The Food and Drug written/paper submissions): Division of Centers for Disease Control and Administration (FDA or Agency) is Dockets Management (HFA–305), Food Prevention and the Agency for Toxic announcing the availability of the draft and Drug Administration, 5630 Fishers Substances and Disease Registry. guidance entitled ‘‘Design Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments mstockstill on DSK4VPTVN1PROD with NOTICES Considerations and Pre-market Elaine L. Baker, Submission Recommendations for submitted to the Division of Dockets Director, Management Analysis and Services Interoperable Medical Devices’’. FDA is Management, FDA will post your Office, Centers for Disease Control and issuing this draft guidance to assist comment, as well as any attachments, Prevention. industry and FDA staff in identifying except for information submitted, [FR Doc. 2016–01443 Filed 1–25–16; 8:45 am] specific considerations related to the marked and identified, as confidential, BILLING CODE 4163–18–P ability of electronic medical devices to if submitted as detailed in safely and effectively exchange and use ‘‘Instructions’’. VerDate Sep<11>2014 21:57 Jan 25, 2016 Jkt 238001 PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 E:\FR\FM\26JAN1.SGM 26JAN1


Document Created: 2018-02-02 12:37:46
Document Modified: 2018-02-02 12:37:46
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
FR Citation81 FR 4302 
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