80 FR 63234 - Advisory Commission on Childhood Vaccines; Request for Nominations for Voting Members

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration

Federal Register Volume 80, Issue 201 (October 19, 2015)

Page Range		63234-63235
FR Document		2015-26462

The Health Resources and Services Administration (HRSA) is requesting nominations to fill six 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).

Federal Register, Volume 80 Issue 201 (Monday, October 19, 2015)

[Federal Register Volume 80, Number 201 (Monday, October 19, 2015)]
[Notices]
[Pages 63234-63235]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-26462]


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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 six 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 or before December 18, 
2015.

ADDRESSES: All nominations are to be submitted to the Director, 
Division of Injury Compensation Programs, Healthcare Systems Bureau 
(HSB),

[[Page 63235]]

HRSA, Parklawn Building, Room 11C-26, 5600 Fishers Lane, Rockville, 
Maryland 20857.

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. 300aa-19, as added by 
Public Law 99-660 and amended, HRSA is requesting nominations for six 
voting members of the ACCV.
    The ACCV advises the Secretary on the implementation of the VICP. 
The 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.
    Specifically, HRSA is requesting nominations for six voting members 
of the ACCV representing: (1) Two health professionals, 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 both shall be a pediatricians; (2) 
two members of the general public, of whom at least one shall be legal 
representative (parent or guardian) of a child who has suffered a 
vaccine related injury or death; and (3) two 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. Nominees will be invited to serve a 3-year 
term beginning the date of appointment.
    The Department of Health and Human Services (HHS or Department) 
will consider nominations of all qualified individuals with a view to 
ensuring that the ACCV includes the areas of subject matter expertise 
noted above. Based on a recommendation made by the ACCV, the Secretary 
will consider having a health professional with expertise in obstetrics 
as the second member of the general public. 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.
    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.
    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.
    The HHS strives to ensure that the membership of the HHS Federal 
Advisory Committee is fairly balanced in terms of points of view 
presented and the committee's function. 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 Committee. Appointment to this 
Committee shall be made without discrimination on basis of age, race, 
ethnicity, gender, sexual orientation, disability, and cultural, 
religious, or socioeconomic status.

Jackie Painter,
Director, Division of the Executive Secretariat.
[FR Doc. 2015-26462 Filed 10-16-15; 8:45 am]
 BILLING CODE 4165-15-P

63234 Federal Register / Vol. 80, No. 201 / Monday, October 19, 2015 / Notices

U.S.C. 360f) to ban devices that present a device may be required to submit to year. Each administrative detention will
substantial deception or an FDA all relevant and available data and have varying amounts of data and
unreasonable and substantial risk of information to enable the Commissioner information that must be maintained.
illness or injury. Section 895.21 (21 CFR to determine whether the device FDA’s estimate of the burden under the
895.21), on banned devices, contains presents substantial deception, administrative detention provision is
certain reporting requirements. Section unreasonable and substantial risk of based on FDA’s discussion with one of
895.21(d) describes the procedures for illness or injury, or unreasonable, direct, the firms whose devices had been
banning a device when the and substantial danger to the health of detained.
Commissioner of Food and Drugs (the individuals.
Commissioner) decides to initiate such During the past several years, there FDA estimates the burden of this
a proceeding. Under 21 CFR 895.22, a has been an average of less than one collection of information as follows:
manufacturer, distributor, or importer of new administrative detention action per

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
21 CFR section responses per burden per Total hours
respondents responses
respondent response

800.55(g) .............................................................................. 1 1 1 25 25
895.21(d)(8) and 895.22(a) .................................................. 26 1 26 16 416

Total .............................................................................. ........................ ........................ ........................ ........................ 441
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Average
Number of Total annual
21 CFR section records per burden per Total hours
recordkeepers records
recordkeeper recordkeeping

800.55(k) .............................................................................. 1 1 1 20 20
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: October 13, 2015. Georgia Ave., Suite 400, Silver Spring, DEPARTMENT OF HEALTH AND
Leslie Kux, MD 20910–3492. HUMAN SERVICES
Associate Commissioner for Policy.
FOR FURTHER INFORMATION CONTACT: Health Resources and Services
[FR Doc. 2015–26440 Filed 10–16–15; 8:45 am]
Deborah Kallgren, Office of Women’s Administration
BILLING CODE 4164–01–P
Health, Food and Drug Administration,
10903 New Hampshire Ave., Silver Advisory Commission on Childhood
DEPARTMENT OF HEALTH AND Spring, MD 20993–0002, 301–796–9440, Vaccines; Request for Nominations for
HUMAN SERVICES FAX: 301–847–8604, deborah.kallgren@ Voting Members
fda.hhs.gov.
AGENCY: Health Resources and Services
Food and Drug Administration SUPPLEMENTARY INFORMATION: There is Administration, HHS.
[Docket No. FDA–2015–N–0001] no fee, but pre-registration is required. ACTION: Notice.
Send registration information (including
Office of Women’s Health Update on name, title, organization name, address, SUMMARY: The Health Resources and
Strategic Priorities and Initiatives for telephone, and fax number) to Deborah Services Administration (HRSA) is
Nurses Kallgren. Seating is limited to 35 requesting nominations to fill six
AGENCY: Food and Drug Administration, participants (1 person per organization). vacancies on the Advisory Commission
HHS. on Childhood Vaccines (ACCV). The
If you need special accommodations ACCV was established by Title XXI of
ACTION: Notice of meeting. due to a disability, please contact the Public Health Service Act (the Act),
Deborah Kallgren (see FOR FURTHER as enacted by Public Law (Pub. L.) 99–
SUMMARY: The Food and Drug
INFORMATION CONTACT) at least 7 days in 660 and as subsequently amended, and
Administration (FDA) is announcing the
following meeting: Office of Women’s advance. advises the Secretary of Health and
Health Update on Strategic Priorities Dated: October 13, 2015. Human Services (the Secretary) on
and Initiatives. FDA staff will provide Leslie Kux, issues related to implementation of the
updates on strategic priorities, National Vaccine Injury Compensation
asabaliauskas on DSK5VPTVN1PROD with NOTICES

Associate Commissioner for Policy.
educational outreach, and research Program (VICP).
[FR Doc. 2015–26433 Filed 10–16–15; 8:45 am]
initiatives of interest to national DATES: The agency will receive
BILLING CODE 4164–01–P
organizations for nursing professionals nominations on or before December 18,
and students. 2015.
DATES: The meeting will be held on ADDRESSES: All nominations are to be
November 18, 2015, 1 p.m. to 3 p.m. submitted to the Director, Division of
ADDRESSES: The meeting will be held at Injury Compensation Programs,
the American Nurses Association, 8515 Healthcare Systems Bureau (HSB),

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Federal Register / Vol. 80, No. 201 / Monday, October 19, 2015 / Notices 63235

HRSA, Parklawn Building, Room 11C– includes representation of vaccine Financial Disclosure Report, OGE Form
26, 5600 Fishers Lane, Rockville, manufacturers. In addition, the Director 450, to provide detailed information
Maryland 20857. of the National Institutes of Health, the concerning financial interests,
FOR FURTHER INFORMATION CONTACT: Ms. Assistant Secretary for Health, the consultancies, research grants, and/or
Annie Herzog, Principal Staff Liaison, Director of the Centers for Disease contracts that might be affected by
Division of Injury Compensation Control and Prevention, and the recommendations made by the ACCV.
Programs, HSB, HRSA, at (301) 443– Commissioner of the Food and Drug A nomination package should include
6634 or email: aherzog@hrsa.gov. Administration (or the designees of such the following information for each
SUPPLEMENTARY INFORMATION: Under the
officials) serve as nonvoting ex officio nominee: (1) A letter of nomination
authorities that established the ACCV, members. stating the name, affiliation, and contact
Specifically, HRSA is requesting information for the nominee, the basis
the Federal Advisory Committee Act of
nominations for six voting members of for the nomination (i.e., what specific
October 6, 1972 (Pub. L. 92–463) and
the ACCV representing: (1) Two health attributes, perspectives, and/or skills
section 2119 of the Act, 42 U.S.C. 300aa-
professionals, who have expertise in the does the individual possess that would
19, as added by Public Law 99–660 and
health care of children, the benefit the workings of the ACCV) and
amended, HRSA is requesting
epidemiology, etiology, and prevention the nominee’s field(s) of expertise; (2) a
nominations for six voting members of
of childhood diseases, and the adverse biographical sketch of the nominee and
the ACCV.
reactions associated with vaccines, of a copy of his/her curriculum vitae; and
The ACCV advises the Secretary on
whom both shall be a pediatricians; (2) (3) the name, address, daytime
the implementation of the VICP. The
two members of the general public, of telephone number, and email address at
activities of the ACCV include:
whom at least one shall be legal which the nominator can be contacted.
Recommending changes in the Vaccine
representative (parent or guardian) of a The HHS strives to ensure that the
Injury Table at its own initiative or as
child who has suffered a vaccine related membership of the HHS Federal
the result of the filing of a petition; injury or death; and (3) two attorneys,
advising the Secretary in implementing Advisory Committee is fairly balanced
of whom at least one shall be an in terms of points of view presented and
section 2127 of the Act regarding the attorney whose specialty includes
need for childhood vaccination the committee’s function. Every effort is
representation of persons who have made to ensure that the views of
products that result in fewer or no suffered a vaccine-related injury or
significant adverse reactions; surveying women, all ethnic and racial groups,
death, and of whom one shall be an and people with disabilities are
federal, state, and local programs and attorney whose specialty includes
activities related to gathering represented on HHS Federal Advisory
representation of vaccine Committees and, therefore, the
information on injuries associated with manufacturers. Nominees will be
the administration of childhood Department encourages nominations of
invited to serve a 3-year term beginning qualified candidates from these groups.
vaccines, including the adverse reaction the date of appointment.
reporting requirements of section The Department also encourages
The Department of Health and Human
2125(b) of the Act; advising the geographic diversity in the composition
Services (HHS or Department) will
Secretary on the methods of obtaining, of the Committee. Appointment to this
consider nominations of all qualified
compiling, publishing, and using Committee shall be made without
individuals with a view to ensuring that
credible data related to the frequency discrimination on basis of age, race,
the ACCV includes the areas of subject
and severity of adverse reactions ethnicity, gender, sexual orientation,
matter expertise noted above. Based on
associated with childhood vaccines; disability, and cultural, religious, or
a recommendation made by the ACCV,
consulting on the development or socioeconomic status.
the Secretary will consider having a
revision of Vaccine Information health professional with expertise in Jackie Painter,
Statements; and recommending to the obstetrics as the second member of the Director, Division of the Executive Secretariat.
Director of the National Vaccine general public. Interested persons may [FR Doc. 2015–26462 Filed 10–16–15; 8:45 am]
Program research related to vaccine nominate one or more qualified persons BILLING CODE 4165–15–P
injuries which should be conducted to for membership on the ACCV.
carry out the VICP. Nominations shall state that the
The ACCV consists of nine voting nominee is willing to serve as a member DEPARTMENT OF HEALTH AND
members appointed by the Secretary as of the ACCV. HUMAN SERVICES
follows: (1) Three health professionals, ACCV members are appointed as
who are not employees of the United Special Government Employees. As Office of the Secretary
States Government, and who have such, they are covered by the federal
expertise in the health care of children, ethics rules, including the criminal [Document Identifier: OS–0990–XXXX]
the epidemiology, etiology, and conflict of interest statutes governing Agency Information Collection
prevention of childhood diseases, and executive branch employees. For Activities; Submission to OMB for
the adverse reactions associated with example, an ACCV member may be Review and Approval; Public Comment
vaccines, of whom at least two shall be prohibited from discussions about
Request
pediatricians; (2) three members from making changes to the Vaccine Injury
the general public, of whom at least two Table and Vaccine Information AGENCY: Office of the Secretary, HHS.
shall be legal representatives (parents or Statements for the Hepatitis B vaccine if
asabaliauskas on DSK5VPTVN1PROD with NOTICES

ACTION: Notice.
guardians) of children who have he/she or his/her spouse owns stock
suffered a vaccine related injury or valued above a certain amount in SUMMARY: In compliance with section
death; and (3) three attorneys, of whom companies which manufacturer this 3507(a)(1)(D) of the Paperwork
at least one shall be an attorney whose vaccine, affecting their own pecuniary Reduction Act of 1995, the Office of the
specialty includes representation of interests—including interests imputed Secretary (OS), Department of Health
persons who have suffered a vaccine- to them. To evaluate possible conflicts and Human Services, has submitted an
related injury or death, and of whom of interest, potential candidates will be Information Collection Request (ICR),
one shall be an attorney whose specialty asked to fill out the Confidential described below, to the Office of

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Document Created: 2015-12-15 08:35:36
Document Modified: 2015-12-15 08:35:36

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		The agency will receive nominations on or before December 18, 2015.
Contact		Ms. Annie Herzog, Principal Staff Liaison, Division of Injury Compensation Programs, HSB, HRSA, at (301) 443-6634 or email: [email protected]
FR Citation		80 FR 63234

80 FR 63234 - Advisory Commission on Childhood Vaccines; Request for Nominations for Voting Members

DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth Resources and Services Administration

Federal Register Volume 80, Issue 201 (October 19, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration