Advisory Commission on Childhood Vaccines, 14865-14866 [2018-07007]
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Federal Register / Vol. 83, No. 67 / Friday, April 6, 2018 / Notices
burden differs and is specific to medical
gas manufacturing.
14865
FDA estimates the burden of this
collection of information as follows:
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN
[Medical Gases] 1
Number of
recordkeepers
21 CFR section/activity
SOP Maintenance .......................................................................
New startup SOPs ......................................................................
211.34—Consultants ...................................................................
211.67(c)—Equipment cleaning and maintenance .....................
211.68—Changes in master production and control records or
other records.
211.68(a)—Automatic, mechanical, and electronic equipment ..
211.68(b)—Computer or related systems ..................................
211.72—Filters ............................................................................
211.80(d)—Components and drug product containers or closures.
211.100(b)—Production and process controls ...........................
211.105(b)—Equipment identification .........................................
211.122(c)—Labeling and packaging material ...........................
211.130(e)—Labeling and packaging facilities ...........................
211.132(c)—Tamper-evident packaging .....................................
211.132(d)—Tamper-evident packaging ....................................
211.137—Expiration dating .........................................................
211.160(a)—Laboratory controls ................................................
211.165(e)—Test methodology ..................................................
211.166—Stability testing ...........................................................
211.173—Laboratory animals .....................................................
211.180(e)—Production, control, and distribution records .........
211.180(f)—Procedures for notification of regulatory actions ....
211.182—Equipment cleaning and use log ................................
211.184—Component, drug product container, closure, and labeling records.
211.186—Master production and control records ......................
211.188—Batch production and control records ........................
211.192—Discrepancies in drug product production and control records.
211.194—Laboratory records .....................................................
211.196—Distribution records ....................................................
211.198—Complaint files ............................................................
211.204—Returned drug products .............................................
Total .....................................................................................
1 Burden
Number of
records per
recordkeeper
Total annual
records
Total hours
2,284
100
2,284
2,284
2,284
0.65
25
0.25
32.5
2
1,485
2,500
571
74,230
4,568
25 .........................................
20 .........................................
0.5 (30 minutes) ..................
0.25 (15 minutes) ................
1 ...........................................
37,125
50,000
286
18,558
4,568
2,284
2,284
2,284
2,284
10
5
.25
0.25
22,840
11,420
571
571
0.5 (30 minutes) ..................
0.25 (15 minutes) ................
1 ...........................................
0.1 (6 minutes) ....................
11,420
2,855
571
57
2,284
2,284
2,284
2,284
2,284
2,284
2,284
2,284
2,284
2,284
2,284
2,284
2,284
2,284
2,284
3
0.25
50
50
20
.2
3.25
2
1
1.3
1
0.2
0.2
1.3
1.95
6,382
571
114,200
114,200
45,680
457
7,423
4,568
2,284
2,969
2,284
457
457
2,969
4,454
2 ...........................................
0.25 (15 minutes) ................
0.25 (15 minutes) ................
0.25 (15 minutes) ................
0.5 (30 minutes) ..................
0.5 (30 minutes) ..................
0.33 (20 minutes) ................
1 ...........................................
1 ...........................................
0.33 (20 minutes) ................
0.25 (15 minutes) ................
0.25 (15 minutes) ................
1 ...........................................
0.16 (10 minutes) ................
0.33 (20 minutes) ................
13,704
143
28,550
28,550
22,840
229
2,450
4,568
2,284
980
571
114
457
475
1,470
2,284
2,284
2,284
10
16.25
2
22,840
37,115
4,568
2 ...........................................
1.3 ........................................
1 ...........................................
45,680
48,250
4,568
2,284
2,284
2,284
2,284
..........................
25
25
5
10
..........................
57,100
57,100
11,420
22,840
........................
0.5 (30 minutes) ..................
0.25 (15 minutes) ................
1 ...........................................
0.5 (30 minutes) ..................
..............................................
28,550
14,275
11,420
11,420
396,988
estimates of less than 1 hour are expressed as a fraction of an hour in the format ‘‘[number of minutes per response]/60’’.
The information collection reflects an
increase in the number of respondents
that results in a corresponding increase
to the number of annual burden hours.
This is consistent with our experience
with the information collection.
[FR Doc. 2018–07031 Filed 4–5–18; 8:45 am]
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), and
advises the Secretary of HHS (the
Secretary) on issues related to
implementation of the National Vaccine
Injury Compensation Program (VICP).
BILLING CODE 4164–01–P
DATES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ADDRESSES:
Dated: April 2, 2018.
Leslie Kux,
Associate Commissioner for Policy.
Advisory Commission on Childhood
Vaccines
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice—Request for
nominations for voting members.
AGENCY:
VerDate Sep<11>2014
19:21 Apr 05, 2018
SUMMARY:
The agency will receive
nominations on a continuous basis.
Health Resources and Services
Administration
daltland on DSKBBV9HB2PROD with NOTICES
Average burden
per recordkeeping
(in hours) 1
Jkt 244001
Submit your nominations to
the Director, Division of Injury
Compensation Programs (DICP),
Healthcare Systems Bureau (HSB),
HRSA, 5600 Fishers Lane, Room
08N146B, Rockville, Maryland 20857.
Submit your electronic nomination
package by email to Ms. Annie Herzog
at AHerzog@hrsa.gov.
Ms.
Annie Herzog, Principal Staff Liaison,
DICP, HSB, HRSA, at (301) 443–6634 or
email at aherzog@hrsa.gov.
FOR FURTHER INFORMATION CONTACT:
PO 00000
Frm 00024
Fmt 4703
Sfmt 4703
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 voting members of the
ACCV.
The ACCV advises the Secretary on
the implementation of the VICP. Other
activities of the ACCV include:
Recommending changes to the Vaccine
Injury Table, at its own initiative or as
the result of the filing of a petition;
advising the Secretary on 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
SUPPLEMENTARY INFORMATION:
E:\FR\FM\06APN1.SGM
06APN1
daltland on DSKBBV9HB2PROD with NOTICES
14866
Federal Register / Vol. 83, No. 67 / Friday, April 6, 2018 / Notices
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.
HHS 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.
Additionally, 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.
VerDate Sep<11>2014
19:21 Apr 05, 2018
Jkt 244001
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 that 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 U.S. Office of
Government Ethics (OGE) 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 or
email communication and 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 at that time.
HHS strives to ensure that the
membership of the ACCV is 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, HHS
encourages nominations of qualified
candidates from these groups. HHS also
encourages geographic diversity in the
PO 00000
Frm 00025
Fmt 4703
Sfmt 4703
composition of the Committee.
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. HHS
encourages nominations of qualified
candidates from all groups and
locations.
Dated: March 30, 2018.
Lori A. Roche,
Acting Deputy, Division of the Executive
Secretariat.
[FR Doc. 2018–07007 Filed 4–5–18; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Solicitation of Nominations for
Membership To Serve on the Advisory
Committee on Heritable Disorders in
Newborns and Children
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Request for nominations.
AGENCY:
HRSA is seeking nominations
of qualified candidates to be considered
for appointment as members of the
Advisory Committee on Heritable
Disorders in Newborns and Children
(Committee). The Committee provides
advice, recommendations, and technical
information about aspects of heritable
disorders and newborn and childhood
screening to the Secretary of HHS.
HRSA is seeking nominations of
qualified candidates to fill up to three
positions on the Committee.
DATE: Written nominations for
membership on the Committee must be
received on or before April 30, 2018.
ADDRESSES: Nomination packages must
be submitted electronically as email
attachments to Alaina Harris, Genetic
Services Branch, Maternal and Child
Health Bureau (MCHB), HRSA,
AHarris@hrsa.gov.
FOR FURTHER INFORMATION CONTACT:
Alaina Harris. Address: MCHB, HRSA,
5600 Fishers Lane, Room 18W66,
Rockville, MD 20857; phone number:
(301) 443–0721; email: AHarris@
hrsa.gov. A copy of the Committee
Charter and list of the current
membership can be obtained by
accessing the Committee website at
www.hrsa.gov/advisory-committees/
heritable-disorders.
SUPPLEMENTARY INFORMATION: The
Committee was established in 2003 to
advise the Secretary of HHS regarding
newborn screening tests, technologies,
policies, guidelines, and programs for
SUMMARY:
E:\FR\FM\06APN1.SGM
06APN1
Agencies
[Federal Register Volume 83, Number 67 (Friday, April 6, 2018)]
[Notices]
[Pages 14865-14866]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07007]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Advisory Commission on Childhood Vaccines
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice--Request for nominations for voting members.
-----------------------------------------------------------------------
SUMMARY: 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),
and advises the Secretary of HHS (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: Submit your nominations to the Director, Division of Injury
Compensation Programs (DICP), Healthcare Systems Bureau (HSB), HRSA,
5600 Fishers Lane, Room 08N146B, Rockville, Maryland 20857. Submit your
electronic nomination package by email to Ms. Annie Herzog at
[email protected].
FOR FURTHER INFORMATION CONTACT: Ms. Annie Herzog, Principal Staff
Liaison, DICP, HSB, HRSA, at (301) 443-6634 or email at
[email protected]
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
voting members of the ACCV.
The ACCV advises the Secretary on the implementation of the VICP.
Other activities of the ACCV include: Recommending changes to the
Vaccine Injury Table, at its own initiative or as the result of the
filing of a petition; advising the Secretary on 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
[[Page 14866]]
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.
HHS 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.
Additionally, 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
that 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 U.S. Office of Government Ethics (OGE) 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 or email communication and
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 at that time.
HHS strives to ensure that the membership of the ACCV is 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, HHS encourages nominations
of qualified candidates from these groups. HHS also encourages
geographic diversity in the composition of the Committee. 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. HHS encourages nominations of
qualified candidates from all groups and locations.
Dated: March 30, 2018.
Lori A. Roche,
Acting Deputy, Division of the Executive Secretariat.
[FR Doc. 2018-07007 Filed 4-5-18; 8:45 am]
BILLING CODE 4165-15-P