Nominations to the Presidential Advisory Council on HIV/AIDS, 54299-54300 [2015-22610]

Download as PDF Federal Register / Vol. 80, No. 174 / Wednesday, September 9, 2015 / Notices 54299 TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of recordkeepers Section of guidance/recordkeeping activity Number of records per recordkeeper Total annual records Average burden per recordkeeping Total hours 4.1. and 6.4 SOPs for DMCs ....................................... 4.4.3.2. DMC meeting records ..................................... 37 370 1 1 37 370 8 ............................ 2 ............................ 296 740 Total ...................................................................... ........................ ........................ ........................ ............................... 1,036 1 There are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 Number of disclosures per respondent Number of respondents Section of guidance/disclosure activity Total annual disclosures Average burden per disclosure Total hours 4.4.1.2. Sponsor notification to the DMC regarding waivers. 4.4.3.2. DMC reports of meeting minutes to the sponsor. 1 1 1 0.25 (15 minutes) .. 0.25 370 2 740 1 ............................ 740 Total ...................................................................... ........................ ........................ ........................ ............................... 740.25 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: September 3, 2015. Leslie Kux, Associate Commissioner for Policy. prevention and care of HIV disease and AIDS. The functions of the Council are solely advisory in nature. DATES: All nominations must be received no later than 5:00 p.m. (ET) on October 9, 2015 at the address listed below. [FR Doc. 2015–22680 Filed 9–8–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Nominations to the Presidential Advisory Council on HIV/AIDS Department of Health and Human Services, Office of the Secretary, Office of the Assistant Secretary for Health. ACTION: Notice. AGENCY: The Office of the Assistant Secretary for Health (OASH) is seeking nominations of qualified individuals to be considered for appointment as members of the Presidential Advisory Council on HIV/AIDS (PACHA). The PACHA is a federal advisory committee within the Department of Health and Human Services (HHS). Management support for the activities of this Council is the responsibility of the OASH. The qualified individuals will be nominated to the Secretary of Health and Human Services for consideration for appointment as members of the PACHA. Members of the Council, including the Chair, are appointed by the Secretary. Members are invited to serve on the Council for up to four-year terms. The Council was established to provide advice, information, and recommendations to the Secretary regarding programs and policies intended to promote effective Lhorne on DSK5TPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 14:19 Sep 08, 2015 Jkt 235001 All nominations should be mailed or delivered to Ms. B. Kaye Hayes, Executive Director, PACHA, Department of Health and Human Services, Office of HIV/AIDS and Infectious Disease Policy, 200 Independence Avenue SW., Room 443– H, Washington, DC 20201. FOR FURTHER INFORMATION CONTACT: Ms. Caroline Talev, Public Health Analyst, Presidential Advisory Council on HIV/ AIDS, Department of Health and Human Services, 200 Independence Avenue SW., Room 443–H, Hubert H. Humphrey Building, Washington, DC 20201; (202) 205–1178. More detailed information about PACHA can be obtained by accessing the Council’s page at the AIDS.gov Web site at www.aids.gov/ pacha. ADDRESSES: PACHA was established by Executive Order 12963, dated June 14, 1995, as amended by Executive Order 13009, dated June 14, 1996. The Council was established to provide advice, information, and recommendations to the Secretary regarding programs and policies intended to promote effective prevention and care of HIV disease and AIDS. The functions of the Council are solely advisory in nature. The Council consists of not more than 25 members. Council members are SUPPLEMENTARY INFORMATION: PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 selected from prominent community leaders with particular expertise in, or knowledge of, matters concerning HIV and AIDS, public health, global health, philanthropy, marketing or business, as well as other national leaders held in high esteem from other sectors of society. Council members are appointed by the Secretary or designee, in consultation with the White House Office on National AIDS Policy. Pursuant to advance written agreement, Council members shall receive no stipend for the advisory service they render as members of PACHA. However, as authorized by law and in accordance with federal travel regulations, PACHA members may receive per diem and reimbursement for travel expenses incurred in relation to performing duties for the Council. This announcement is to solicit nominations of qualified candidates to fill current vacancies on the PACHA. Nominations: In accordance with the PACHA charter, persons nominated for appointment as members of the PACHA should be among prominent community leaders and authorities with particular expertise in, or knowledge of, matters concerning HIV and AIDS, public health, global health, philanthropy, marketing or business, as well as other national leaders held in high esteem from other sectors of society. The following information should be included in the package of material submitted for each individual being nominated for consideration of appointment: • Name, return address, daytime telephone number, and affiliation(s) of E:\FR\FM\09SEN1.SGM 09SEN1 Lhorne on DSK5TPTVN1PROD with NOTICES 54300 Federal Register / Vol. 80, No. 174 / Wednesday, September 9, 2015 / Notices the individual being nominated, the basis for the individual’s nomination, and a statement bearing an original signature of the nominated individual that, if appointed, he or she is willing to serve as a member of the Council; • Name, return address, and daytime telephone number at which the nominator may be contacted. Nominations from organizations must identify a principal contact person; and a • Copy of a current resume or curriculum vitae for the nominated individual. Individuals can nominate themselves for consideration of appointment to the Council. All nominations must include the required information. Incomplete nominations will not be processed for consideration. The letter from the nominator and certification of the nominated individual must bear original signatures; reproduced copies of these signatures are not acceptable. The Department is legally required to ensure that the membership of HHS federal advisory committees is fairly balanced in terms of points of view represented and the functions to be performed by the advisory committee. Every effort is made to ensure that the views of women, all ethnic and racial groups, and people with disabilities are represented on HHS federal advisory committees and, therefore, the Department encourages nominations of qualified candidates from these groups. The Department also encourages geographic diversity in the composition of the Council. Appointment to the Council shall be made without discrimination on the basis of age, race, ethnicity, gender, sexual orientation, disability, and cultural, religious, or socioeconomic status. The Standards of Ethical Conduct for Employees of the Executive Branch are applicable to individuals who are appointed as members of the Council. Individuals being considered for appointment as public voting members will be required to complete and submit a report of their financial holdings. An ethics review must be conducted to ensure that individuals appointed as members of PACHA are not involved in any activity that may pose a potential conflict of interest for the official duties that are to be performed. Dated: August 24, 2015. B. Kaye Hayes, Executive Director, Presidential Advisory Council on HIV/AIDS. [FR Doc. 2015–22610 Filed 9–8–15; 8:45 am] BILLING CODE 4150–43–P VerDate Sep<11>2014 14:19 Sep 08, 2015 Jkt 235001 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Announcement of Public Consultation on Antimicrobial Resistance Rapid, Point-of-Care Diagnostic Test Challenge Authority: 15 U.S.C. 3719. The U.S. Department of Health and Human Services (HHS) intends to hold a prize competition in which up to $20 million will be made available, subject to the availability of funds, for the delivery of one or more successful rapid point-of-care diagnostics that may be used by health care providers to identify bacterial infections. The National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA) are sponsoring the prize competition and will convene a public consultation to seek comments regarding the technical criteria and performance characteristics of the diagnostic(s) for which the prize(s) will be offered. DATES: The public consultation will be held on October 7, 2015, 8:30 a.m. to 3:30 p.m. PDT. Written comments can be submitted to the https:// www.challenges.gov Web site for this competition beginning on October 1 at 8:30 a.m. EDT to October 6, 2015 at 5:00 p.m. EDT. ADDRESSES: The public consultation will be held at the Marriott Marquis San Diego Marina, 333 West Harbor Drive, San Diego, California, 92101. FOR FURTHER INFORMATION CONTACT: Robert W. Eisinger, Ph.D., National Institutes of Health, Division of Program Coordination, Planning, and Strategic Initiatives, Telephone: 301–496–2229, Email: Robert.eisinger@nih.gov. SUPPLEMENTARY INFORMATION: On September 18, 2014, the President issued Executive Order 13676 on Combating Antibiotic-Resistant Bacteria (https://www.whitehouse.gov/the-pressoffice/2014/09/18/executive-ordercombating-antibiotic-resistant-bacteria) and the Antimicrobial Resistance Challenge was called for in the accompanying White House Fact Sheet https://www.whitehouse.gov/the-pressoffice/2014/09/18/fact-sheet-obamaadministration-takes-actions-combatantibiotic-resistan). The development and use of rapid, point-of-care, and innovative diagnostic tests for identification and characterization of resistant bacteria was a goal identified in the National Strategy for Combating Antibiotic-Resistant Bacteria released in SUMMARY: PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 September 2014 (https:// www.whitehouse.gov/sites/default/files/ docs/carb_national_strategy.pdf) and addressed in the National Action Plan for Combating Antibiotic-Resistant Bacteria released in March 2015 (https://www.whitehouse.gov/sites/ default/files/docs/national_action_ plan_for_combating_antibotic-resistant_ bacteria.pdf). In conformance to the above documents, the NIH and BARDA are sponsoring a prize competition, and the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are contributing technical and regulatory expertise to develop the award evaluation process. The aim of the prize competition is to incentivize the development of one or more in vitro diagnostic tests that would be of significant clinical and public health utility to combat the development and spread of antibiotic resistant bacteria. For example, such a diagnostic test could be used by health care providers to identify bacterial infections in patients to help guide their decisions about the necessity of prescribing antibiotics, and if so, which antibiotics may be effective—thus promoting antibiotic stewardship. Another important diagnostic use could be to facilitate clinical trials for new antibacterial products by allowing for the enrichment of patient populations with specific infections, thus advancing the development of new antibacterial agents. The prize-winning diagnostic(s) must exhibit a set of predefined technical criteria and performance characteristics based on the intended use(s). When exercising prize authority under the America COMPETES Act (http://www.gpo.gov/fdsys/pkg/PLAW– 111publ358/html/PLAW– 111publ358.htm), agencies are to ‘‘consult widely both within and outside the federal Government’’ when developing prize competitions. As such, HHS is seeking input from the medical, public health, and scientific communities; the pharmaceutical and medical diagnostic sectors; patients and other advocacy groups; and the public at-large in order to receive broad input on the type(s) of diagnostic(s) that may be developed in an appropriate time frame to be of significant utility in combating the development and spread of antibiotic resistant bacteria. HHS has previously issued a Request for Information (RFI) to obtain comments on several topics as they pertain to a rapid, point-of-care diagnostic test(s) that could be developed in an appropriate time frame to be of significant clinical and public E:\FR\FM\09SEN1.SGM 09SEN1

Agencies

[Federal Register Volume 80, Number 174 (Wednesday, September 9, 2015)]
[Notices]
[Pages 54299-54300]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-22610]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Nominations to the Presidential Advisory Council on HIV/AIDS

AGENCY: Department of Health and Human Services, Office of the 
Secretary, Office of the Assistant Secretary for Health.

ACTION: Notice.

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

SUMMARY: The Office of the Assistant Secretary for Health (OASH) is 
seeking nominations of qualified individuals to be considered for 
appointment as members of the Presidential Advisory Council on HIV/AIDS 
(PACHA). The PACHA is a federal advisory committee within the 
Department of Health and Human Services (HHS). Management support for 
the activities of this Council is the responsibility of the OASH. The 
qualified individuals will be nominated to the Secretary of Health and 
Human Services for consideration for appointment as members of the 
PACHA. Members of the Council, including the Chair, are appointed by 
the Secretary. Members are invited to serve on the Council for up to 
four-year terms. The Council was established to provide advice, 
information, and recommendations to the Secretary regarding programs 
and policies intended to promote effective prevention and care of HIV 
disease and AIDS. The functions of the Council are solely advisory in 
nature.

DATES: All nominations must be received no later than 5:00 p.m. (ET) on 
October 9, 2015 at the address listed below.

ADDRESSES: All nominations should be mailed or delivered to Ms. B. Kaye 
Hayes, Executive Director, PACHA, Department of Health and Human 
Services, Office of HIV/AIDS and Infectious Disease Policy, 200 
Independence Avenue SW., Room 443-H, Washington, DC 20201.

FOR FURTHER INFORMATION CONTACT: Ms. Caroline Talev, Public Health 
Analyst, Presidential Advisory Council on HIV/AIDS, Department of 
Health and Human Services, 200 Independence Avenue SW., Room 443-H, 
Hubert H. Humphrey Building, Washington, DC 20201; (202) 205-1178. More 
detailed information about PACHA can be obtained by accessing the 
Council's page at the AIDS.gov Web site at www.aids.gov/pacha.

SUPPLEMENTARY INFORMATION: PACHA was established by Executive Order 
12963, dated June 14, 1995, as amended by Executive Order 13009, dated 
June 14, 1996. The Council was established to provide advice, 
information, and recommendations to the Secretary regarding programs 
and policies intended to promote effective prevention and care of HIV 
disease and AIDS. The functions of the Council are solely advisory in 
nature.
    The Council consists of not more than 25 members. Council members 
are selected from prominent community leaders with particular expertise 
in, or knowledge of, matters concerning HIV and AIDS, public health, 
global health, philanthropy, marketing or business, as well as other 
national leaders held in high esteem from other sectors of society. 
Council members are appointed by the Secretary or designee, in 
consultation with the White House Office on National AIDS Policy. 
Pursuant to advance written agreement, Council members shall receive no 
stipend for the advisory service they render as members of PACHA. 
However, as authorized by law and in accordance with federal travel 
regulations, PACHA members may receive per diem and reimbursement for 
travel expenses incurred in relation to performing duties for the 
Council.
    This announcement is to solicit nominations of qualified candidates 
to fill current vacancies on the PACHA.
    Nominations: In accordance with the PACHA charter, persons 
nominated for appointment as members of the PACHA should be among 
prominent community leaders and authorities with particular expertise 
in, or knowledge of, matters concerning HIV and AIDS, public health, 
global health, philanthropy, marketing or business, as well as other 
national leaders held in high esteem from other sectors of society. The 
following information should be included in the package of material 
submitted for each individual being nominated for consideration of 
appointment:
     Name, return address, daytime telephone number, and 
affiliation(s) of

[[Page 54300]]

the individual being nominated, the basis for the individual's 
nomination, and a statement bearing an original signature of the 
nominated individual that, if appointed, he or she is willing to serve 
as a member of the Council;
     Name, return address, and daytime telephone number at 
which the nominator may be contacted. Nomina tions from organizations 
must identify a principal contact person; and a
     Copy of a current resume or curriculum vitae for the 
nominated individual.
    Individuals can nominate themselves for consideration of 
appointment to the Council. All nominations must include the required 
information. Incomplete nominations will not be processed for 
consideration. The letter from the nominator and certification of the 
nominated individual must bear original signatures; reproduced copies 
of these signatures are not acceptable.
    The Department is legally required to ensure that the membership of 
HHS federal advisory committees is fairly balanced in terms of points 
of view represented and the functions to be performed by the advisory 
committee. Every effort is made to ensure that the views of women, all 
ethnic and racial groups, and people with disabilities are represented 
on HHS federal advisory committees and, therefore, the Department 
encourages nominations of qualified candidates from these groups. The 
Department also encourages geographic diversity in the composition of 
the Council. Appointment to the Council shall be made without 
discrimination on the basis of age, race, ethnicity, gender, sexual 
orientation, disability, and cultural, religious, or socioeconomic 
status. The Standards of Ethical Conduct for Employees of the Executive 
Branch are applicable to individuals who are appointed as members of 
the Council. Individuals being considered for appointment as public 
voting members will be required to complete and submit a report of 
their financial holdings. An ethics review must be conducted to ensure 
that individuals appointed as members of PACHA are not involved in any 
activity that may pose a potential conflict of interest for the 
official duties that are to be performed.

    Dated: August 24, 2015.
B. Kaye Hayes,
Executive Director, Presidential Advisory Council on HIV/AIDS.
[FR Doc. 2015-22610 Filed 9-8-15; 8:45 am]
 BILLING CODE 4150-43-P