Advisory Commission on Childhood Vaccines; Request for Nominations for Voting Members, 63234-63235 [2015-26462]
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Federal Register / Vol. 80, No. 201 / Monday, October 19, 2015 / Notices
U.S.C. 360f) to ban devices that present
substantial deception or an
unreasonable and substantial risk of
illness or injury. Section 895.21 (21 CFR
895.21), on banned devices, contains
certain reporting requirements. Section
895.21(d) describes the procedures for
banning a device when the
Commissioner of Food and Drugs (the
Commissioner) decides to initiate such
a proceeding. Under 21 CFR 895.22, a
manufacturer, distributor, or importer of
a device may be required to submit to
FDA all relevant and available data and
information to enable the Commissioner
to determine whether the device
presents substantial deception,
unreasonable and substantial risk of
illness or injury, or unreasonable, direct,
and substantial danger to the health of
individuals.
During the past several years, there
has been an average of less than one
new administrative detention action per
year. Each administrative detention will
have varying amounts of data and
information that must be maintained.
FDA’s estimate of the burden under the
administrative detention provision is
based on FDA’s discussion with one of
the firms whose devices had been
detained.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
800.55(g) ..............................................................................
895.21(d)(8) and 895.22(a) ..................................................
1
26
1
1
1
26
25
16
25
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
21 CFR section
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
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.
Leslie Kux,
Associate Commissioner for Policy.
Georgia Ave., Suite 400, Silver Spring,
MD 20910–3492.
FOR FURTHER INFORMATION CONTACT:
[FR Doc. 2015–26440 Filed 10–16–15; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Office of Women’s Health Update on
Strategic Priorities and Initiatives for
Nurses
Food and Drug Administration,
HHS.
Notice of meeting.
The Food and Drug
Administration (FDA) is announcing the
following meeting: Office of Women’s
Health Update on Strategic Priorities
and Initiatives. FDA staff will provide
updates on strategic priorities,
educational outreach, and research
initiatives of interest to national
organizations for nursing professionals
and students.
DATES: The meeting will be held on
November 18, 2015, 1 p.m. to 3 p.m.
ADDRESSES: The meeting will be held at
the American Nurses Association, 8515
asabaliauskas on DSK5VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:52 Oct 16, 2015
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There is
no fee, but pre-registration is required.
Send registration information (including
name, title, organization name, address,
telephone, and fax number) to Deborah
Kallgren. Seating is limited to 35
participants (1 person per organization).
If you need special accommodations
due to a disability, please contact
Deborah Kallgren (see FOR FURTHER
INFORMATION CONTACT) at least 7 days in
advance.
SUPPLEMENTARY INFORMATION:
[Docket No. FDA–2015–N–0001]
ACTION:
Health Resources and Services
Administration
Deborah Kallgren, Office of Women’s
Health, Food and Drug Administration,
10903 New Hampshire Ave., Silver
Spring, MD 20993–0002, 301–796–9440,
FAX: 301–847–8604, deborah.kallgren@
fda.hhs.gov.
BILLING CODE 4164–01–P
AGENCY:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: October 13, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–26433 Filed 10–16–15; 8:45 am]
BILLING CODE 4164–01–P
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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 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),
SUMMARY:
E:\FR\FM\19OCN1.SGM
19OCN1
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 201 / Monday, October 19, 2015 / Notices
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. 300aa19, 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 vaccinerelated injury or death, and of whom
one shall be an attorney whose specialty
VerDate Sep<11>2014
17:52 Oct 16, 2015
Jkt 238001
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
PO 00000
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63235
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
[Document Identifier: OS–0990–XXXX]
Agency Information Collection
Activities; Submission to OMB for
Review and Approval; Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, has submitted an
Information Collection Request (ICR),
described below, to the Office of
SUMMARY:
E:\FR\FM\19OCN1.SGM
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]]>Agencies
[Federal Register Volume 80, Number 201 (Monday, October 19, 2015)]
[Notices]
[Pages 63234-63235]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-26462]
-----------------------------------------------------------------------
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
