Retail Pharmacy Interest in Utilization of Innovative Educational Technology To Increase Human Papillomavirus (HPV) Vaccination Rates in Rural Areas, 4482-4483 [2019-02548]
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Federal Register / Vol. 84, No. 32 / Friday, February 15, 2019 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
respondents
21 CFR section; activity
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Use of veterinary master files during all phases of product
development (including product development that precedes the establishment of an INAD file or the submission of a NADA) ...............................................................
15
1
15
20
300
Total ..............................................................................
........................
........................
1,022
........................
22,083
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
2 NADAs and supplements regarding antimicrobial animal drugs that use a recommended approach to assessing antimicrobial concerns as
part of the overall preapproval safety evaluation.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our previous estimates.
However, as discussed, we have
separately estimated the burden of the
‘‘Use of veterinary master files during
all phases of product development
(including product development that
precedes the establishment of an INAD
file or the submission of an NADA)’’ in
table 1, row 10. We base our estimate of
the total annual responses for the use of
veterinary master files on such uses
initiated during calendar year 2018. We
base our estimate of the hours per
response upon our experience with the
respondents’ use of veterinary master
files. We estimate that the time it takes
to compile information and submit it to
a veterinary master file will vary from
1 to 50 hours, depending on the
complexity of the information;
therefore, we are estimating on average
the burden per response to be 20 hours.
Accordingly, we report an additional
300 burden hours and 15 total annual
responses in row 10. We are also
correcting several rounding errors that
were made in our last request for OMB
approval. Correcting these rounding
errors reduces our previously reported
total burden hours and total responses.
Thus, our estimated burden for the
information collection reflects a net
overall increase of 124 hours and a
corresponding increase of 14 responses.
Dated: February 11, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–02479 Filed 2–14–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Advisory Council on Blood Stem Cell
Transplantation
Health Resources and Services
Administration (HRSA), the Department
of Health and Human Services (HHS).
ACTION: Notice of charter renewal.
AGENCY:
HHS is hereby giving notice
that the Advisory Council on Blood
Stem Cell Transplantation (ACBSCT)
has been renewed. The effective date of
the renewed charter is February 19,
2019.
SUMMARY:
ACBSCT charter authorizes the Council
to operate until February 19, 2021.
A copy of the ACBSCT charter is
available on the ACBSCT website at:
https://bloodcell.transplant.hrsa.gov/
about/advisory_council/. A
copy of the charter can also be obtained
by accessing the FACA database that is
maintained by the Committee
Management Secretariat under the
General Services Administration. The
website address for the FACA database
is https://www.facadatabase.gov/.
Amy P. McNulty,
Acting Director, Division of the Executive
Secretariat.
[FR Doc. 2019–02399 Filed 2–14–19; 8:45 am]
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FOR FURTHER INFORMATION CONTACT:
Robert Walsh, Executive Secretary,
ACBSCT, HRSA, 5600 Fishers Lane,
Rockville, Maryland 20857. Phone: 301–
443–6839; email: rwalsh@hrsa.gov.
SUPPLEMENTARY INFORMATION: Relevant
statutes are Public Law 109–129 as
amended by Public Law 111–264; 42
U.S.C. 274k; and Section 379 of the
Public Health Service Act. The Council
is governed by the provisions of Public
Law 92–463, as amended (5 U.S.C.
appendix 2), which sets forth standards
for the formation and use of advisory
committees.
ACBSCT advises and makes
recommendations to the Secretary of
Health and Human Services (Secretary)
on matters related to the activities of the
C.W. Bill Young Cell Transplantation
Program and the National Cord Blood
Inventory Program. One of its principal
functions shall be to provide
consolidated, comprehensive sources of
expert, unbiased analysis and
recommendations to the Secretary on
the latest advances in the science of
blood stem cell transplantation.
ACBSCT may meet up to three times
during the fiscal year. The charter
renewal for ACBSCT was approved on
February 7, 2019. The filing date is
February 19, 2019. Renewal of the
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Retail Pharmacy Interest in Utilization
of Innovative Educational Technology
To Increase Human Papillomavirus
(HPV) Vaccination Rates in Rural Areas
National Vaccine Program
Office, Office of the Assistant Secretary
for Health, Office of the Secretary,
Department of Health and Human
Services.
ACTION: Notice.
AGENCY:
This request for information
(RFI) is issued for informational and
planning purposes only. This RFI is not
a solicitation; nor does it commit the
Department of Health and Human
Services (HHS) to issue a solicitation,
make any award, or pay any costs
associated with responding to this
announcement.
The RFI is being issued by the
National Vaccine Program Office
(NVPO) of the U.S. Department of
Health and Human Services. The NVPO
is located in the Office of the Assistant
Secretary for Health (ASH), Office of the
Secretary (OS), U.S. Department of
Health and Human Services (HHS). The
NVPO provides strategic leadership and
SUMMARY:
E:\FR\FM\15FEN1.SGM
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Federal Register / Vol. 84, No. 32 / Friday, February 15, 2019 / Notices
management, policy scholarship and
recommendations, and encourages
collaboration and coordination among
federal agencies and other stakeholders
whose mission is to reduce the burden
of preventable infectious disease
through immunization. NVPO offers
thorough reporting, unbiased advice and
expertise to other agencies in
identifying and responding to gaps in
the vaccine system.
Prevention of cancers associated with
Human Papillomavirus (HPV) infections
continues to be a public health
challenge in the United States.
Vaccination is an effective, primary
medical intervention for prevention of
infection from these viruses. Despite
this, HPV vaccination series completion
rates remain low nationwide, with
adolescents living in rural communities
(per census definition of <50,000
population) having a significantly lower
HPV vaccination coverage when
compared to their urban or suburban
counterparts.
In accordance with policy
recommendations from the National
Vaccine Advisory Committee and efforts
to promote HPV-vaccination coverage in
rural areas, NVPO is seeking
information on the level of interest of
retail pharmacies in utilizing innovative
educational models for both providers
and customers to increase HPVvaccination rates in rural areas.
DATES: Information from retail
pharmacies with greater than 100 stores
in geographic areas considered to be
rural by the census definition (<50,000
population) should submit responses to
this RFI as described in the addresses
section below no later than midnight,
12:00 a.m. EDT on February 25, 2019.
ADDRESSES: Responses should be
submitted in Portable Document Format
(PDF) only and be sent via email to
nvpo@hhs.gov. The name(s) of all PDF
files uploaded should begin with
‘‘NVPO_RFI_Pharmacy’’ followed by the
organization name and the sequential
number of the file, if more than one file
is submitted. All submissions
responsive to this RFI must be made as
indicated above. Mailed paper
submissions will not be reviewed.
FOR FURTHER INFORMATION CONTACT:
National Vaccine Program Office, Office
of the Assistant Secretary for Health,
Department of Health and Human
Services; telephone (202) 690–5566;
email: nvpo@hhs.gov.
SUPPLEMENTARY INFORMATION: Responses
to this RFI should be in the format
outlined below. Primary responses
should be limited to no more than 30
pages, 12 point, Times New Roman font,
using a minimum of one-inch margins.
VerDate Sep<11>2014
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Supplementary material may be
included in appendices and will not
count toward the page limitation.
Section 1—General Information
Responses to this RFI should include
(1) the organization’s full name, (2)
headquarters location, and (3) a
description of interest level in utilizing
innovative educational models for both
providers and customers to increase
HPV vaccine series completion and
thereby lower vaccine preventable HPVassociated cancers.
Section 2—Qualifications and
Experience
Provide a description of corporate
experience in developing and/or
implementing innovative educational
models for both (1) retail pharmacy
providers, and (2) customers as part of
health messaging, i.e. to increase
vaccination rates.
Section 3—Recommendations for
Execution
Provide recommendations or lessons
learned while developing and/or
implementing an innovative educational
model for retail pharmacy providers and
customers to increase HPV-vaccination
rates.
Section 4—Likelihood of Participation
Comment on the likelihood of your
firm to submit a proposal for the
utilization of innovative educational
technology to increase HPV vaccination
rates in rural areas.
Companies are invited to respond to
this request for information if they meet
at least three of the following criteria:
1. Are a national retail pharmacy with
greater than 100 stores in geographic
areas considered to be rural by the
census definition (<50,000
population)
2. Are a national employer
3. Have an immunization provider (i.e.
nurse, pharmacist, physician) on site
in their stores
4. Stores must stock and administer
Human Papillomavirus (HPV) vaccine
5. Have existing virtual reality (VR)
platform employee training in place
6. Have both brick-and-mortar locations
and a website by which consumers
can make purchases
7. Have existing patient/consumer
health education campaigns
8. Have a least one site with the
designation of ‘Centers of Excellence
in Specialized Pharmacy Care’
Responders should include point-ofcontact information including email and
postal mailing address.
Responses to any of the above areas
are welcome; respondents are not
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4483
required to address all the issues
identified in the request. Public release
of the data submitted is governed by the
Freedom of Information Act (https://
www.hhs.gov/foia/). Response to the RFI
will not be returned.
Dated: February 1, 2019.
Tammy Beckham,
Acting Director, National Vaccine Program
Office.
[FR Doc. 2019–02548 Filed 2–14–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases Notice of Closed
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, 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 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, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Allergy, Immunology,
and Transplantation Research Committee;
Allergy, Immunology, and Transplantation
Research Committee (AITC) September 2019
Council.
Date: June 13–14, 2019.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 5601
Fishers Lane, Rockville, MD 20892
(Telephone Conference Call).
Contact Person: James T. Snyder, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
Room 3G31B, National Institutes of Health,
NIAID, 5601 Fishers Lane, MSC 9834,
Bethesda, MD 20892–9834, (240) 669–5060,
james.snyder@nih.gov.
Name of Committee: Allergy, Immunology,
and Transplantation Research Committee;
Allergy, Immunology, and Transplantation
Research Committee (AITC) January 2020
Council.
Date: October 24–25, 2019.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 5601
Fishers Lane, Rockville, MD 20892
(Telephone Conference Call).
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]]>Agencies
[Federal Register Volume 84, Number 32 (Friday, February 15, 2019)]
[Notices]
[Pages 4482-4483]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-02548]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Retail Pharmacy Interest in Utilization of Innovative Educational
Technology To Increase Human Papillomavirus (HPV) Vaccination Rates in
Rural Areas
AGENCY: National Vaccine Program Office, Office of the Assistant
Secretary for Health, Office of the Secretary, Department of Health and
Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This request for information (RFI) is issued for informational
and planning purposes only. This RFI is not a solicitation; nor does it
commit the Department of Health and Human Services (HHS) to issue a
solicitation, make any award, or pay any costs associated with
responding to this announcement.
The RFI is being issued by the National Vaccine Program Office
(NVPO) of the U.S. Department of Health and Human Services. The NVPO is
located in the Office of the Assistant Secretary for Health (ASH),
Office of the Secretary (OS), U.S. Department of Health and Human
Services (HHS). The NVPO provides strategic leadership and
[[Page 4483]]
management, policy scholarship and recommendations, and encourages
collaboration and coordination among federal agencies and other
stakeholders whose mission is to reduce the burden of preventable
infectious disease through immunization. NVPO offers thorough
reporting, unbiased advice and expertise to other agencies in
identifying and responding to gaps in the vaccine system.
Prevention of cancers associated with Human Papillomavirus (HPV)
infections continues to be a public health challenge in the United
States. Vaccination is an effective, primary medical intervention for
prevention of infection from these viruses. Despite this, HPV
vaccination series completion rates remain low nationwide, with
adolescents living in rural communities (per census definition of
<50,000 population) having a significantly lower HPV vaccination
coverage when compared to their urban or suburban counterparts.
In accordance with policy recommendations from the National Vaccine
Advisory Committee and efforts to promote HPV-vaccination coverage in
rural areas, NVPO is seeking information on the level of interest of
retail pharmacies in utilizing innovative educational models for both
providers and customers to increase HPV-vaccination rates in rural
areas.
DATES: Information from retail pharmacies with greater than 100 stores
in geographic areas considered to be rural by the census definition
(<50,000 population) should submit responses to this RFI as described
in the addresses section below no later than midnight, 12:00 a.m. EDT
on February 25, 2019.
ADDRESSES: Responses should be submitted in Portable Document Format
(PDF) only and be sent via email to nvpo@hhs.gov. The name(s) of all
PDF files uploaded should begin with ``NVPO_RFI_Pharmacy'' followed by
the organization name and the sequential number of the file, if more
than one file is submitted. All submissions responsive to this RFI must
be made as indicated above. Mailed paper submissions will not be
reviewed.
FOR FURTHER INFORMATION CONTACT: National Vaccine Program Office,
Office of the Assistant Secretary for Health, Department of Health and
Human Services; telephone (202) 690-5566; email: nvpo@hhs.gov.
SUPPLEMENTARY INFORMATION: Responses to this RFI should be in the
format outlined below. Primary responses should be limited to no more
than 30 pages, 12 point, Times New Roman font, using a minimum of one-
inch margins. Supplementary material may be included in appendices and
will not count toward the page limitation.
Section 1--General Information
Responses to this RFI should include (1) the organization's full
name, (2) headquarters location, and (3) a description of interest
level in utilizing innovative educational models for both providers and
customers to increase HPV vaccine series completion and thereby lower
vaccine preventable HPV-associated cancers.
Section 2--Qualifications and Experience
Provide a description of corporate experience in developing and/or
implementing innovative educational models for both (1) retail pharmacy
providers, and (2) customers as part of health messaging, i.e. to
increase vaccination rates.
Section 3--Recommendations for Execution
Provide recommendations or lessons learned while developing and/or
implementing an innovative educational model for retail pharmacy
providers and customers to increase HPV-vaccination rates.
Section 4--Likelihood of Participation
Comment on the likelihood of your firm to submit a proposal for the
utilization of innovative educational technology to increase HPV
vaccination rates in rural areas.
Companies are invited to respond to this request for information if
they meet at least three of the following criteria:
1. Are a national retail pharmacy with greater than 100 stores in
geographic areas considered to be rural by the census definition
(<50,000 population)
2. Are a national employer
3. Have an immunization provider (i.e. nurse, pharmacist, physician) on
site in their stores
4. Stores must stock and administer Human Papillomavirus (HPV) vaccine
5. Have existing virtual reality (VR) platform employee training in
place
6. Have both brick-and-mortar locations and a website by which
consumers can make purchases
7. Have existing patient/consumer health education campaigns
8. Have a least one site with the designation of `Centers of Excellence
in Specialized Pharmacy Care'
Responders should include point-of-contact information including
email and postal mailing address.
Responses to any of the above areas are welcome; respondents are
not required to address all the issues identified in the request.
Public release of the data submitted is governed by the Freedom of
Information Act (https://www.hhs.gov/foia/). Response to the RFI will
not be returned.
Dated: February 1, 2019.
Tammy Beckham,
Acting Director, National Vaccine Program Office.
[FR Doc. 2019-02548 Filed 2-14-19; 8:45 am]
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