83 FR 14865 - Advisory Commission on Childhood Vaccines

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration

Federal Register Volume 83, Issue 67 (April 6, 2018)

Page Range		14865-14866
FR Document		2018-07007

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).

Federal Register, Volume 83 Issue 67 (Friday, April 6, 2018)

[Federal Register Volume 83, Number 67 (Friday, April 6, 2018)]
[Notices]
[Pages 14865-14866]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-07007]


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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.

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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 
AHerzog@hrsa.gov.

FOR FURTHER INFORMATION CONTACT: Ms. Annie Herzog, Principal Staff 
Liaison, DICP, HSB, HRSA, at (301) 443-6634 or email at 
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 
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

Federal Register / Vol. 83, No. 67 / Friday, April 6, 2018 / Notices 14865

burden differs and is specific to medical FDA estimates the burden of this
gas manufacturing. collection of information as follows:
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN
[Medical Gases] 1

Number of Average burden
Number of Total annual
21 CFR section/activity records per per recordkeeping Total hours
recordkeepers records
recordkeeper (in hours) 1

SOP Maintenance ....................................................................... 2,284 0.65 1,485 25 ......................................... 37,125
New startup SOPs ...................................................................... 100 25 2,500 20 ......................................... 50,000
211.34—Consultants ................................................................... 2,284 0.25 571 0.5 (30 minutes) .................. 286
211.67(c)—Equipment cleaning and maintenance ..................... 2,284 32.5 74,230 0.25 (15 minutes) ................ 18,558
211.68—Changes in master production and control records or 2,284 2 4,568 1 ........................................... 4,568
other records.
211.68(a)—Automatic, mechanical, and electronic equipment .. 2,284 10 22,840 0.5 (30 minutes) .................. 11,420
211.68(b)—Computer or related systems .................................. 2,284 5 11,420 0.25 (15 minutes) ................ 2,855
211.72—Filters ............................................................................ 2,284 .25 571 1 ........................................... 571
211.80(d)—Components and drug product containers or clo- 2,284 0.25 571 0.1 (6 minutes) .................... 57
sures.
211.100(b)—Production and process controls ........................... 2,284 3 6,382 2 ........................................... 13,704
211.105(b)—Equipment identification ......................................... 2,284 0.25 571 0.25 (15 minutes) ................ 143
211.122(c)—Labeling and packaging material ........................... 2,284 50 114,200 0.25 (15 minutes) ................ 28,550
211.130(e)—Labeling and packaging facilities ........................... 2,284 50 114,200 0.25 (15 minutes) ................ 28,550
211.132(c)—Tamper-evident packaging ..................................... 2,284 20 45,680 0.5 (30 minutes) .................. 22,840
211.132(d)—Tamper-evident packaging .................................... 2,284 .2 457 0.5 (30 minutes) .................. 229
211.137—Expiration dating ......................................................... 2,284 3.25 7,423 0.33 (20 minutes) ................ 2,450
211.160(a)—Laboratory controls ................................................ 2,284 2 4,568 1 ........................................... 4,568
211.165(e)—Test methodology .................................................. 2,284 1 2,284 1 ........................................... 2,284
211.166—Stability testing ........................................................... 2,284 1.3 2,969 0.33 (20 minutes) ................ 980
211.173—Laboratory animals ..................................................... 2,284 1 2,284 0.25 (15 minutes) ................ 571
211.180(e)—Production, control, and distribution records ......... 2,284 0.2 457 0.25 (15 minutes) ................ 114
211.180(f)—Procedures for notification of regulatory actions .... 2,284 0.2 457 1 ........................................... 457
211.182—Equipment cleaning and use log ................................ 2,284 1.3 2,969 0.16 (10 minutes) ................ 475
211.184—Component, drug product container, closure, and la- 2,284 1.95 4,454 0.33 (20 minutes) ................ 1,470
beling records.
211.186—Master production and control records ...................... 2,284 10 22,840 2 ........................................... 45,680
211.188—Batch production and control records ........................ 2,284 16.25 37,115 1.3 ........................................ 48,250
211.192—Discrepancies in drug product production and con- 2,284 2 4,568 1 ........................................... 4,568
trol records.
211.194—Laboratory records ..................................................... 2,284 25 57,100 0.5 (30 minutes) .................. 28,550
211.196—Distribution records .................................................... 2,284 25 57,100 0.25 (15 minutes) ................ 14,275
211.198—Complaint files ............................................................ 2,284 5 11,420 1 ........................................... 11,420
211.204—Returned drug products ............................................. 2,284 10 22,840 0.5 (30 minutes) .................. 11,420
Total ..................................................................................... .......................... .......................... ........................ .............................................. 396,988

1 Burden 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 SUMMARY: HRSA is requesting SUPPLEMENTARY INFORMATION: Under the
increase in the number of respondents nominations to fill vacancies on the authorities that established the ACCV,
that results in a corresponding increase Advisory Commission on Childhood the Federal Advisory Committee Act of
to the number of annual burden hours. Vaccines (ACCV). The ACCV was October 6, 1972, (Pub. L. 92–463) and
This is consistent with our experience established by Title XXI of the Public section 2119 of the Act, 42 U.S.C.
with the information collection. Health Service Act (the Act), and 300aa–19, as added by Public Law 99–
Dated: April 2, 2018. advises the Secretary of HHS (the 660 and amended, HRSA is requesting
Leslie Kux, Secretary) on issues related to nominations for voting members of the
Associate Commissioner for Policy. implementation of the National Vaccine ACCV.
[FR Doc. 2018–07031 Filed 4–5–18; 8:45 am] Injury Compensation Program (VICP). The ACCV advises the Secretary on
the implementation of the VICP. Other
BILLING CODE 4164–01–P DATES:The agency will receive activities of the ACCV include:
nominations on a continuous basis. Recommending changes to the Vaccine
DEPARTMENT OF HEALTH AND ADDRESSES: Submit your nominations to Injury Table, at its own initiative or as
HUMAN SERVICES the Director, Division of Injury the result of the filing of a petition;
Compensation Programs (DICP), advising the Secretary on implementing
Health Resources and Services Healthcare Systems Bureau (HSB), section 2127 of the Act regarding the
Administration HRSA, 5600 Fishers Lane, Room need for childhood vaccination
08N146B, Rockville, Maryland 20857. products that result in fewer or no
Advisory Commission on Childhood significant adverse reactions; surveying
Submit your electronic nomination
daltland on DSKBBV9HB2PROD with NOTICES

Vaccines federal, state, and local programs and
package by email to Ms. Annie Herzog
AGENCY: Health Resources and Services at AHerzog@hrsa.gov. activities related to gathering
Administration (HRSA), Department of information on injuries associated with
Health and Human Services (HHS). FOR FURTHER INFORMATION CONTACT: Ms. the administration of childhood
Annie Herzog, Principal Staff Liaison, vaccines, including the adverse reaction
ACTION: Notice—Request for
DICP, HSB, HRSA, at (301) 443–6634 or reporting requirements of section
nominations for voting members.
email at aherzog@hrsa.gov. 2125(b) of the Act; advising the

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14866 Federal Register / Vol. 83, No. 67 / Friday, April 6, 2018 / Notices

Secretary on the methods of obtaining, ACCV members are appointed as composition of the Committee.
compiling, publishing, and using Special Government Employees. As Appointment to the ACCV shall be
credible data related to the frequency such, they are covered by the federal made without discrimination on basis of
and severity of adverse reactions ethics rules, including the criminal age, race, ethnicity, gender, sexual
associated with childhood vaccines; conflict of interest statutes governing orientation, disability, and cultural,
consulting on the development or executive branch employees. For religious, or socioeconomic status. HHS
revision of Vaccine Information example, an ACCV member may be encourages nominations of qualified
Statements; and recommending to the prohibited from discussions about candidates from all groups and
Director of the National Vaccine making changes to the Vaccine Injury locations.
Program research related to vaccine Table and Vaccine Information Dated: March 30, 2018.
injuries which should be conducted to Statements for the Hepatitis B vaccine if
Lori A. Roche,
carry out the VICP. he/she or his/her spouse owns stock
The ACCV consists of nine voting valued above a certain amount in Acting Deputy, Division of the Executive
members appointed by the Secretary as Secretariat.
companies that manufacturer this
follows: (1) Three health professionals, [FR Doc. 2018–07007 Filed 4–5–18; 8:45 am]
vaccine, affecting their own pecuniary
who are not employees of the United interests—including interests imputed BILLING CODE 4165–15–P
States Government, and who have to them. To evaluate possible conflicts
expertise in the health care of children, of interest, potential candidates will be
the epidemiology, etiology, and asked to fill out the U.S. Office of DEPARTMENT OF HEALTH AND
prevention of childhood diseases, and Government Ethics (OGE) Confidential HUMAN SERVICES
the adverse reactions associated with Financial Disclosure Report, OGE Form Solicitation of Nominations for
vaccines, of whom at least two shall be 450, to provide detailed information Membership To Serve on the Advisory
pediatricians; (2) three members from concerning financial interests,
Committee on Heritable Disorders in
the general public, of whom at least two consultancies, research grants, and/or
Newborns and Children
shall be legal representatives (parents or contracts that might be affected by
guardians) of children who have recommendations made by the ACCV. AGENCY: Health Resources and Services
suffered a vaccine-related injury or Interested persons may nominate one Administration (HRSA), Department of
death; and (3) three attorneys, of whom or more qualified persons for Health and Human Services (HHS).
at least one shall be an attorney whose membership on the ACCV. Nominations ACTION: Request for nominations.
specialty includes representation of shall state that the nominee is willing to
persons who have suffered a vaccine- serve as a member of the ACCV. SUMMARY: HRSA is seeking nominations
related injury or death, and of whom Nominees will be invited to serve a 3- of qualified candidates to be considered
one shall be an attorney whose specialty year term beginning the date of for appointment as members of the
includes representation of vaccine appointment. A nomination package Advisory Committee on Heritable
manufacturers. In addition, the Director should be submitted as hard copy or Disorders in Newborns and Children
of the National Institutes of Health, the email communication and should (Committee). The Committee provides
Assistant Secretary for Health, the include the following information for advice, recommendations, and technical
Director of the Centers for Disease each nominee: (1) A letter of nomination information about aspects of heritable
Control and Prevention, and the stating the name, affiliation, and contact disorders and newborn and childhood
Commissioner of the Food and Drug information for the nominee, the basis screening to the Secretary of HHS.
Administration (or the designees of such for the nomination (i.e., what specific HRSA is seeking nominations of
officials) serve as nonvoting ex officio attributes, perspectives, and/or skills qualified candidates to fill up to three
members. does the individual possess that would positions on the Committee.
HHS will consider nominations of all benefit the workings of the ACCV) and DATE: Written nominations for
qualified individuals with a view to the nominee’s field(s) of expertise; (2) a membership on the Committee must be
ensure that the ACCV includes the areas biographical sketch of the nominee and received on or before April 30, 2018.
of subject matter expertise noted above. a copy of his/her curriculum vitae; and ADDRESSES: Nomination packages must
As indicated above, at least two of the (3) the name, address, daytime be submitted electronically as email
three ACCV members of the general telephone number, and email address at
attachments to Alaina Harris, Genetic
public must be legal representatives which the nominator can be contacted.
Services Branch, Maternal and Child
(parents or guardians) of children who Nomination packages will be collected
Health Bureau (MCHB), HRSA,
have suffered a vaccine-related injury or and retained to create a pool of possible
death. Because those members must be AHarris@hrsa.gov.
future ACCV voting members. When a
the legal representatives of children vacancy occurs, nomination packages FOR FURTHER INFORMATION CONTACT:
who have suffered a vaccine-related from the appropriate category will be Alaina Harris. Address: MCHB, HRSA,
injury or death, to be considered for reviewed and nominees may be 5600 Fishers Lane, Room 18W66,
appointment to the ACCV in that contacted at that time. Rockville, MD 20857; phone number:
category there must have been a finding HHS strives to ensure that the (301) 443–0721; email: AHarris@
(i.e., a decision) by the U.S. Court of membership of the ACCV is balanced in hrsa.gov. A copy of the Committee
Federal Claims or a civil court that a terms of points of view presented and Charter and list of the current
VICP-covered vaccine caused, or was the committee’s function. Every effort is membership can be obtained by
presumed to have caused, the made to ensure that the views of accessing the Committee website at
daltland on DSKBBV9HB2PROD with NOTICES

represented child’s injury or death. women, all ethnic and racial groups, www.hrsa.gov/advisory-committees/
Additionally, based on a and people with disabilities are heritable-disorders.
recommendation made by the ACCV, represented on HHS Federal Advisory SUPPLEMENTARY INFORMATION: The
the Secretary will consider having a Committees and, therefore, HHS Committee was established in 2003 to
health professional with expertise in encourages nominations of qualified advise the Secretary of HHS regarding
obstetrics as one of the members of the candidates from these groups. HHS also newborn screening tests, technologies,
general public. encourages geographic diversity in the policies, guidelines, and programs for

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Document Created: 2018-11-01 09:16:03
Document Modified: 2018-11-01 09:16:03

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--Request for nominations for voting members.
Dates		The agency will receive nominations on a continuous basis.
Contact		Ms. Annie Herzog, Principal Staff Liaison, DICP, HSB, HRSA, at (301) 443-6634 or email at [email protected]
FR Citation		83 FR 14865

83 FR 14865 - Advisory Commission on Childhood Vaccines

DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth Resources and Services Administration

Federal Register Volume 83, Issue 67 (April 6, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration