Advisory Commission on Childhood Vaccines; Request for Nominations for Voting Members, 41316-41317 [2016-14960]

Download as PDF 41316 Federal Register / Vol. 81, No. 122 / Friday, June 24, 2016 / Notices Health Policy (FORHP) funds grant programs supporting expanding access to, coordinating, restraining the cost of, and improving the quality of essential health care services in rural and frontier communities. Small rural hospitals are facing many challenges in the new health care environment, including the concurrent need to better measure and account for quality of care in all settings; improve transitions of care as patients move from one care setting to another; the evolution of new payment approaches such as value-based purchasing; and, new approaches to care delivery such as accountable care organizations (ACO) and patientcentered medical homes. Success in this new environment will require bridging the gaps between the current system and the newly emerging system of healthcare delivery and payment. Because little is known about how these new models might impact rural communities, there is a need to help hospitals understand and consider those factors that would make them logical participants in health care systems that focus on value. The SRHT, also funded by Section 330A, will assist small rural hospitals facing these challenges. The purpose of the project is to provide on- site technical assistance to nine small rural hospitals residing in persistent poverty counties. Technical assistance will be provided in the areas of: (1) Financial assessments, (2) creating a quality-focused environment, (3) aligning services to community need, and, (4) to the extent that financial and quality core areas have been stabilized, provide assistance to help recipients of technical assistance consider factors that would make them logical participants in health care systems that focus on value (for example ACOs, shared savings programs, primary care medical homes). Need and Proposed Use of the Information: SRHT includes a deliverable to design processes for developing, receiving, reviewing, and scoring hospital applications for participation in the SRHT project. The processes will ensure that the selection of applicants is consistent with established criteria and hospitals’ readiness or ability to implement consultants’ recommendations. Specifically, the application form will be designed to solicit information that will be scored and ranked to aid in the selection of nine small rural hospitals to receive on-site technical assistance. Number of respondents Form name SRHT Online Application ..................................................... Assessment: Performance Excellence for Rural Hospitals Total .............................................................................. 30 30 30 * Number of responses per respondent Likely Respondents: Small rural hospitals located in a rural community, as defined by FORHP, persistent poverty county or a rural census tract of a metro persistent poverty county and have 49 staffed beds or less as reported on the hospital’s most recently filed Medicare Cost Report. Hospitals may be for-profit or not-for-profit. Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose or provide the information requested. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information; to search data sources; to complete and review the collection of information; and to transmit or otherwise disclose the information. The total annual burden hours estimated for this ICR are summarized in the table below. Total Estimated Annualized burden hours: Total responses 38 29 ........................ 1,140 870 2,010 Average burden per response (in hours) .50 .25 ........................ Total burden hours 570 217.5 787.5 * The same individuals complete the SRHT Online Application and the Assessment for a total of 30 respondents. HRSA specifically requests comments on: (1) The necessity and utility of the proposed information collection for the proper performance of the agency’s functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. Jason E. Bennett, Director, Division of the Executive Secretariat. sradovich on DSK3GDR082PROD with NOTICES [FR Doc. 2016–14952 Filed 6–23–16; 8:45 am] BILLING CODE 4165–15–P VerDate Sep<11>2014 17:43 Jun 23, 2016 Jkt 238001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Advisory Commission on Childhood Vaccines; Request for Nominations for Voting Members Health Resources and Services Administration, HHS. ACTION: Notice. AGENCY: The Health Resources and Services Administration (HRSA) is requesting nominations to fill vacancies on the Advisory Commission on Childhood Vaccines (ACCV). The ACCV was established by title XXI of the Public Health Service Act (the Act), as enacted by Public Law (Pub. L.) 99–660 and as subsequently amended, and advises the Secretary of Health and Human Services (the Secretary) on SUMMARY: PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 issues related to implementation of the National Vaccine Injury Compensation Program (VICP). DATES: The agency will receive nominations on a continuous basis. ADDRESSES: All nominations are to be submitted to the Director, Division of Injury Compensation Programs, Healthcare Systems Bureau (HSB), HRSA, 5600 Fishers Lane, Room 08N146B, Rockville, Maryland 20857. Nominations submitted electronically should be submitted to AJohnson3@ HRSA.gov or AHerzog@HRSA.gov. FOR FURTHER INFORMATION CONTACT: Ms. Annie Herzog, Principal Staff Liaison, Division of Injury Compensation Programs, HSB, HRSA, at (301) 443– 6634 or email: aherzog@hrsa.gov. SUPPLEMENTARY INFORMATION: Under the authorities that established the ACCV, the Federal Advisory Committee Act of October 6, 1972, (Pub. L. 92–463) and section 2119 of the Act, 42 U.S.C. E:\FR\FM\24JNN1.SGM 24JNN1 sradovich on DSK3GDR082PROD with NOTICES Federal Register / Vol. 81, No. 122 / Friday, June 24, 2016 / Notices 300aa–19, as added by Pub. L. 99–660 and amended, HRSA is requesting nominations for voting members of the ACCV. The ACCV advises the Secretary on the implementation of the VICP. Other activities of the ACCV include: Recommending changes in the Vaccine Injury Table, at its own initiative or as the result of the filing of a petition; advising the Secretary in implementing section 2127 of the Act regarding the need for childhood vaccination products that result in fewer or no significant adverse reactions; surveying federal, state, and local programs and activities related to gathering information on injuries associated with the administration of childhood vaccines, including the adverse reaction reporting requirements of section 2125(b) of the Act; advising the Secretary on the methods of obtaining, compiling, publishing, and using credible data related to the frequency and severity of adverse reactions associated with childhood vaccines; consulting on the development or revision of Vaccine Information Statements; and recommending to the Director of the National Vaccine Program research related to vaccine injuries which should be conducted to carry out the VICP. The ACCV consists of nine voting members appointed by the Secretary as follows: (1) Three health professionals, who are not employees of the United States Government, and who have expertise in the health care of children, the epidemiology, etiology, and prevention of childhood diseases, and the adverse reactions associated with vaccines, of whom at least two shall be pediatricians; (2) three members from the general public, of whom at least two shall be legal representatives (parents or guardians) of children who have suffered a vaccine-related injury or death; and (3) three attorneys, of whom at least one shall be an attorney whose specialty includes representation of persons who have suffered a vaccinerelated injury or death, and of whom one shall be an attorney whose specialty includes representation of vaccine manufacturers. In addition, the Director of the National Institutes of Health, the Assistant Secretary for Health, the Director of the Centers for Disease Control and Prevention, and the Commissioner of the Food and Drug Administration (or the designees of such officials) serve as nonvoting ex officio members. The Department of Health and Human Services (HHS or Department) will consider nominations of all qualified individuals with a view to ensure that VerDate Sep<11>2014 17:43 Jun 23, 2016 Jkt 238001 the ACCV includes the areas of subject matter expertise noted above. As indicated above, at least two of the three ACCV members of the general public must be legal representatives (parents or guardians) of children who have suffered a vaccine-related injury or death. Because those members must be the legal representatives of children who have suffered a vaccine-related injury or death, to be considered for appointment to the ACCV in that category there must have been a finding (i.e., a decision) by the U.S. Court of Federal Claims or a civil court that a VICP-covered vaccine caused, or was presumed to have caused, the represented child’s injury or death. Based on a recommendation made by the ACCV, the Secretary will consider having a health professional with expertise in obstetrics as one of the members of the general public. ACCV members are appointed as Special Government Employees. As such, they are covered by the federal ethics rules, including the criminal conflict of interest statutes governing executive branch employees. For example, an ACCV member may be prohibited from discussions about making changes to the Vaccine Injury Table and Vaccine Information Statements for the Hepatitis B vaccine if he/she or his/her spouse owns stock valued above a certain amount in companies which manufacturer this vaccine, affecting their own pecuniary interests—including interests imputed to them. To evaluate possible conflicts of interest, potential candidates will be asked to fill out the Confidential Financial Disclosure Report, OGE Form 450, to provide detailed information concerning financial interests, consultancies, research grants, and/or contracts that might be affected by recommendations made by the ACCV. Interested persons may nominate one or more qualified persons for membership on the ACCV. Nominations shall state that the nominee is willing to serve as a member of the ACCV. Nominees will be invited to serve a 3year term beginning the date of appointment. A nomination package should be submitted as hard copy, email communication, or compact disk. A nomination package should include the following information for each nominee: (1) A letter of nomination stating the name, affiliation, and contact information for the nominee, the basis for the nomination (i.e., what specific attributes, perspectives, and/or skills does the individual possess that would benefit the workings of the ACCV) and the nominee’s field(s) of expertise; (2) a biographical sketch of the nominee and PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 41317 a copy of his/her curriculum vitae; and (3) the name, address, daytime telephone number, and email address at which the nominator can be contacted. Nomination packages will be collected and retained to create a pool of possible future ACCV voting members. When a vacancy occurs, nomination packages from the appropriate category will be reviewed and nominees may be contacted. HHS strives to ensure that the membership of the HHS Federal Advisory Committee is fairly balanced in terms of points of view represented and the committee’s function. Appointment to the ACCV shall be made without discrimination on basis of age, race, ethnicity, gender, sexual orientation, disability, and cultural, religious, or socioeconomic status. The Department encourages nominations of qualified candidates from all groups and locations. Jason E. Bennett, Director, Division of the Executive Secretariat. [FR Doc. 2016–14960 Filed 6–23–16; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications/ contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications/ contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Cancer Institute Special Emphasis Panel HTLV. Date: July 15, 2016. Time: 11:30 a.m. to 3:00 p.m. Agenda: To review and evaluate contract proposals. Place: National Cancer Institute Shady Grove, 9609 Medical Center Drive, Room 3W032/034, Rockville, MD 20850 (Telephone Conference Call). Contact Person: Kenneth L. Bielat, Ph.D., Scientific Review Officer, Research and Technology and Contract Review Branch, E:\FR\FM\24JNN1.SGM 24JNN1

Agencies

[Federal Register Volume 81, Number 122 (Friday, June 24, 2016)]
[Notices]
[Pages 41316-41317]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-14960]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Advisory Commission on Childhood Vaccines; Request for 
Nominations for Voting Members

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Health Resources and Services Administration (HRSA) is 
requesting nominations to fill vacancies on the Advisory Commission on 
Childhood Vaccines (ACCV). The ACCV was established by title XXI of the 
Public Health Service Act (the Act), as enacted by Public Law (Pub. L.) 
99-660 and as subsequently amended, and advises the Secretary of Health 
and Human Services (the Secretary) on issues related to implementation 
of the National Vaccine Injury Compensation Program (VICP).

DATES: The agency will receive nominations on a continuous basis.

ADDRESSES: All nominations are to be submitted to the Director, 
Division of Injury Compensation Programs, Healthcare Systems Bureau 
(HSB), HRSA, 5600 Fishers Lane, Room 08N146B, Rockville, Maryland 
20857. Nominations submitted electronically should be submitted to 
AJohnson3@HRSA.gov or AHerzog@HRSA.gov.

FOR FURTHER INFORMATION CONTACT: Ms. Annie Herzog, Principal Staff 
Liaison, Division of Injury Compensation Programs, HSB, HRSA, at (301) 
443-6634 or email: aherzog@hrsa.gov.

SUPPLEMENTARY INFORMATION: Under the authorities that established the 
ACCV, the Federal Advisory Committee Act of October 6, 1972, (Pub. L. 
92-463) and section 2119 of the Act, 42 U.S.C.

[[Page 41317]]

300aa-19, as added by Pub. L. 99-660 and amended, HRSA is requesting 
nominations for voting members of the ACCV.
    The ACCV advises the Secretary on the implementation of the VICP. 
Other activities of the ACCV include: Recommending changes in the 
Vaccine Injury Table, at its own initiative or as the result of the 
filing of a petition; advising the Secretary in implementing section 
2127 of the Act regarding the need for childhood vaccination products 
that result in fewer or no significant adverse reactions; surveying 
federal, state, and local programs and activities related to gathering 
information on injuries associated with the administration of childhood 
vaccines, including the adverse reaction reporting requirements of 
section 2125(b) of the Act; advising the Secretary on the methods of 
obtaining, compiling, publishing, and using credible data related to 
the frequency and severity of adverse reactions associated with 
childhood vaccines; consulting on the development or revision of 
Vaccine Information Statements; and recommending to the Director of the 
National Vaccine Program research related to vaccine injuries which 
should be conducted to carry out the VICP.
    The ACCV consists of nine voting members appointed by the Secretary 
as follows: (1) Three health professionals, who are not employees of 
the United States Government, and who have expertise in the health care 
of children, the epidemiology, etiology, and prevention of childhood 
diseases, and the adverse reactions associated with vaccines, of whom 
at least two shall be pediatricians; (2) three members from the general 
public, of whom at least two shall be legal representatives (parents or 
guardians) of children who have suffered a vaccine-related injury or 
death; and (3) three attorneys, of whom at least one shall be an 
attorney whose specialty includes representation of persons who have 
suffered a vaccine-related injury or death, and of whom one shall be an 
attorney whose specialty includes representation of vaccine 
manufacturers. In addition, the Director of the National Institutes of 
Health, the Assistant Secretary for Health, the Director of the Centers 
for Disease Control and Prevention, and the Commissioner of the Food 
and Drug Administration (or the designees of such officials) serve as 
nonvoting ex officio members.
    The Department of Health and Human Services (HHS or Department) 
will consider nominations of all qualified individuals with a view to 
ensure that the ACCV includes the areas of subject matter expertise 
noted above. As indicated above, at least two of the three ACCV members 
of the general public must be legal representatives (parents or 
guardians) of children who have suffered a vaccine-related injury or 
death. Because those members must be the legal representatives of 
children who have suffered a vaccine-related injury or death, to be 
considered for appointment to the ACCV in that category there must have 
been a finding (i.e., a decision) by the U.S. Court of Federal Claims 
or a civil court that a VICP-covered vaccine caused, or was presumed to 
have caused, the represented child's injury or death. Based on a 
recommendation made by the ACCV, the Secretary will consider having a 
health professional with expertise in obstetrics as one of the members 
of the general public.
    ACCV members are appointed as Special Government Employees. As 
such, they are covered by the federal ethics rules, including the 
criminal conflict of interest statutes governing executive branch 
employees. For example, an ACCV member may be prohibited from 
discussions about making changes to the Vaccine Injury Table and 
Vaccine Information Statements for the Hepatitis B vaccine if he/she or 
his/her spouse owns stock valued above a certain amount in companies 
which manufacturer this vaccine, affecting their own pecuniary 
interests--including interests imputed to them. To evaluate possible 
conflicts of interest, potential candidates will be asked to fill out 
the Confidential Financial Disclosure Report, OGE Form 450, to provide 
detailed information concerning financial interests, consultancies, 
research grants, and/or contracts that might be affected by 
recommendations made by the ACCV.
    Interested persons may nominate one or more qualified persons for 
membership on the ACCV. Nominations shall state that the nominee is 
willing to serve as a member of the ACCV. Nominees will be invited to 
serve a 3-year term beginning the date of appointment. A nomination 
package should be submitted as hard copy, email communication, or 
compact disk. A nomination package should include the following 
information for each nominee: (1) A letter of nomination stating the 
name, affiliation, and contact information for the nominee, the basis 
for the nomination (i.e., what specific attributes, perspectives, and/
or skills does the individual possess that would benefit the workings 
of the ACCV) and the nominee's field(s) of expertise; (2) a 
biographical sketch of the nominee and a copy of his/her curriculum 
vitae; and (3) the name, address, daytime telephone number, and email 
address at which the nominator can be contacted. Nomination packages 
will be collected and retained to create a pool of possible future ACCV 
voting members. When a vacancy occurs, nomination packages from the 
appropriate category will be reviewed and nominees may be contacted.
    HHS strives to ensure that the membership of the HHS Federal 
Advisory Committee is fairly balanced in terms of points of view 
represented and the committee's function. Appointment to the ACCV shall 
be made without discrimination on basis of age, race, ethnicity, 
gender, sexual orientation, disability, and cultural, religious, or 
socioeconomic status. The Department encourages nominations of 
qualified candidates from all groups and locations.

Jason E. Bennett,
Director, Division of the Executive Secretariat.
[FR Doc. 2016-14960 Filed 6-23-16; 8:45 am]
 BILLING CODE 4165-15-P
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