82 FR 3006 - Request for Information From Organizations Utilizing Business Models Supporting Private Sector Vaccine Management
DEPARTMENT OF HEALTH AND HUMAN SERVICES Federal Register Volume 82, Issue 6 (January 10, 2017)
Federal Register Volume 82, Issue 6 (January 10, 2017)
| Page Range | 3006-3007 | |
| FR Document | 2017-00245 |
[Federal Register Volume 82, Number 6 (Tuesday, January 10, 2017)] [Notices] [Pages 3006-3007] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-00245] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Request for Information From Organizations Utilizing Business Models Supporting Private Sector Vaccine Management 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 is a Request for Information (RFI) about business models, existing, under development or planned, that support health care providers for any of the components related to private-sector immunization services (e.g., excluding vaccines provided through federal and state programs, such as the Vaccines for Children Program, Children's Health Insurance Program, Medicaid, and Medicare): Vaccine purchase, distribution, storage and handling, inventory management, reporting to Immunization Information Systems (IIS), including models for populating IIS directly/automatically from electronic health records (EHRs), immunization coverage assessment, forecasting vaccine demand, and billing. 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 is responsible for coordinating and ensuring collaboration among the many federal agencies involved in vaccine and immunization activities. The National Vaccine Program was established in compliance with Title XXI of the Public Health Service Act (Pub. L. 99-660) (Sec. 2101) (42 U.S. Code 300aa-et seq (PDF--78 KB)) to achieve optimal prevention of human infectious diseases through immunization and to achieve optimal prevention against adverse reactions to vaccines. Development of a National Vaccine Plan (NVP) has been mandated to the NVPO as a mechanism for the Director of the National Vaccine Program (the Assistant Secretary for Health) to communicate priorities for both federal and non-federal stakeholders regarding vaccine research and the development, testing, licensing, production, procurement, distribution, and effective use of vaccines in order to carry out the program's responsibilities. Goal 4 of the plan, Ensure a Stable Supply of, Access to, and Better Use of Recommended Vaccines in the United States, focuses in part on increasing and improving access to vaccines in health care provider settings. This RFI seeks information on innovative business models to support health care providers to increase and improve their ability to provide immunization services, as described below. In its efforts to promote vaccination coverage across the lifespan, the NVPO is seeking information about business models, existing, under development or planned, that enable health care providers to offer vaccines to their privately-insured/private-pay patients. The NVPO is most interested in innovative business models aimed at reducing any of the barriers to implementing vaccination services such as vaccine purchase, billing, storage and handling, IIS reporting, including models for populating IIS directly/automatically from EHRs, forecasting vaccine demand, and managing private vaccine inventories. In addition, the NVPO is interested in models that can demonstrate improvements in the immunization coverage rates of the patients seen in the health care settings utilizing such models as well as improvements in reporting to IIS. DATES: Information from Organizations Utilizing Business Models Supporting Private Sector Vaccine Management responsive to this RFI should be submitted as described in the ADDRESSES section below no later than midnight, 12:00 a.m. EDT on January 25, 2017. ADDRESSES: Information from Organizations Utilizing Business Models Supporting Private Sector Vaccine Management responsive to this RFI should be submitted in Portable [[Page 3007]] Document Format (PDF) only and be submitted via email to [email protected]. The name(s) of all PDF files uploaded should begin with ``NVPO_RFI_MODEL'' 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: [email protected]. SUPPLEMENTARY INFORMATION: Responses to this RFI should include the organization's full name and headquarters location. They should also include the name of a point-of-contact and his/her email and conventional mailing addresses. Companies are invited to respond to the following request for information: 1. Description of the business model, existing, under development or planned, and how it addresses any of the following: a. Purchase of vaccines for privately-insured/private pay patients b. Bill private insurers for vaccines and vaccine administration c. Proper storage and handling of privately-purchased vaccines d. Management of private vaccine inventories separate from public vaccine inventories e. Report vaccine administration to IIS, including models for populating IIS directly/automatically from EHRs f. Forecast vaccine demand g. Quality improvement efforts to improve vaccination coverage h. Ability to conduct mass vaccination clinics as part of an emergency response i. Implementation of vaccination as part of occupational health clinics (including federally-sponsored occupational health clinics). 2. Description of the practices served, or planned to be served, including geographic locations, patients served (e.g., pediatrics, specialists, health care providers serving adults, etc.), and practice types (e.g., large health system, private practices, group practices, etc.). 3. Summary of any evaluations of the business model's effectiveness in expanding accessibility to vaccines for privately-insured patients to new groups of health care providers who did not previously provide immunizations or to existing health care providers to expand their immunization services and/or improvements in vaccination coverage for patients served by participating practices. This request for information is for informational purposes only and shall not be construed as a solicitation for funding applications/ proposals or as creating an obligation on the part of the government. The government will not pay for the preparation costs of any information submitted in response to this RFI. Responses to any of the above areas are welcome; respondents should not feel compelled to address all the issues identified in the request. Responses will be compiled without company identifiers and shared with HHS Operating Divisions (e.g., the Centers for Disease Control and Prevention) and advisory committees as appropriate. 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. Information collection sponsored by the NVPO required for the purposes of informing the National Vaccine Program and the National Vaccine Plan is not subject to Chapter 35 of title 44, United States Code [the Paperwork Reduction Act] as indicated in 42 U.S.C. 300aa-1 note (section 321 of Pub. L. 99-660). Dated: January 4, 2017. Roula K. Sweis, Chief of Operations and Management, National Vaccine Program Office. [FR Doc. 2017-00245 Filed 1-9-17; 8:45 am] BILLING CODE 4150-44-P
![3006 Federal Register / Vol. 82, No. 6 / Tuesday, January 10, 2017 / Notices
implementation of health objectives for all delegations and re-delegations of The National Vaccine Program was
adolescents, assures liaison occurs with authority made to officials and established in compliance with Title
relevant HHS agencies and offices, and employees of affected organizational XXI of the Public Health Service Act
facilitates access to services for components will continue in them or (Pub. L. 99–660) (§ 2101) (42 U.S. Code
adolescents; (5) negotiates and awards their successors pending further re- 300aa–et seq (PDF—78 KB)) to achieve
grants and enters into cooperative delegation, provided they are consistent optimal prevention of human infectious
agreements and contracts with public with this reorganization. diseases through immunization and to
and nonprofit entities; (6) enters into III. Funds, Personnel, and Equipment. achieve optimal prevention against
interagency agreements with other PHS/ Transfer of organizations and functions adverse reactions to vaccines.
Federal organizations in support of affected by this reorganization shall be Development of a National Vaccine Plan
adolescent health; (7) ensures the accompanied by direct and support (NVP) has been mandated to the NVPO
appropriate exercise of delegated funds, positions, personnel, records, as a mechanism for the Director of the
authorities and responsibilities; (8) equipment, supplies, and other National Vaccine Program (the Assistant
develops a broad range of health resources. Secretary for Health) to communicate
information and health promotion Dated: January 5, 2017. priorities for both federal and non-
materials; (9) supports the planning and Sylvia M. Burwell, federal stakeholders regarding vaccine
conduct of research and evaluation Secretary. research and the development, testing,
studies; (10) designs, manages and [FR Doc. 2017–00312 Filed 1–9–17; 8:45 am] licensing, production, procurement,
monitors evaluation studies, and BILLING CODE 4150–28–P
distribution, and effective use of
information collection review and vaccines in order to carry out the
approval processes; (11) assesses the program’s responsibilities. Goal 4 of the
focus and impact of ongoing programs DEPARTMENT OF HEALTH AND plan, Ensure a Stable Supply of, Access
and activities, and prepares evaluation HUMAN SERVICES to, and Better Use of Recommended
studies and reports; (12) disseminates Vaccines in the United States, focuses in
information about program activities Request for Information From part on increasing and improving access
and research evaluation studies, Organizations Utilizing Business to vaccines in health care provider
including in peer reviewed Models Supporting Private Sector settings. This RFI seeks information on
publications; (13) oversees the Vaccine Management innovative business models to support
implementation and administration of health care providers to increase and
AGENCY: National Vaccine Program
competitive grants and cooperative improve their ability to provide
Office, Office of the Assistant Secretary
agreements, monitors grantee activities, immunization services, as described
for Health, Office of the Secretary,
and prepares analytical reports on below.
Department of Health and Human In its efforts to promote vaccination
program trends; (14) provides training
Services. coverage across the lifespan, the NVPO
and technical assistance for grant
programs and professionals working ACTION: Notice. is seeking information about business
with adolescents, manages capacity SUMMARY: This is a Request for models, existing, under development or
building needs for grant programs, and Information (RFI) about business planned, that enable health care
assesses performance of grantee models, existing, under development or providers to offer vaccines to their
operations; (15) supports the replication planned, that support health care privately-insured/private-pay patients.
and use of evidence-based approaches providers for any of the components The NVPO is most interested in
and fosters innovative strategies in related to private-sector immunization innovative business models aimed at
programs serving adolescents; (16) services (e.g., excluding vaccines reducing any of the barriers to
manages the development of grant provided through federal and state implementing vaccination services such
funding announcements and contract programs, such as the Vaccines for as vaccine purchase, billing, storage and
scopes of work and the review and Children Program, Children’s Health handling, IIS reporting, including
award of program grants; (17) manages Insurance Program, Medicaid, and models for populating IIS directly/
information, education and awareness Medicare): Vaccine purchase, automatically from EHRs, forecasting
activities, and media and press distribution, storage and handling, vaccine demand, and managing private
relations; (18) develops and coordinates inventory management, reporting to vaccine inventories. In addition, the
strategic plans and special initiatives; Immunization Information Systems NVPO is interested in models that can
(19) oversees public health information (IIS), including models for populating demonstrate improvements in the
and promotes OAH programs and IIS directly/automatically from immunization coverage rates of the
partnerships; (20) manages exhibits and electronic health records (EHRs), patients seen in the health care settings
develops visual and other graphic and immunization coverage assessment, utilizing such models as well as
social media materials regarding forecasting vaccine demand, and billing. improvements in reporting to IIS.
adolescent health, and ensures The RFI is being issued by the National DATES: Information from Organizations
compliance with 508 requirements; (21) Vaccine Program Office (NVPO) of the Utilizing Business Models Supporting
manages adolescent health information, U.S. Department of Health and Human Private Sector Vaccine Management
including the OAH Web site and social Services. responsive to this RFI should be
media, consistent with the policies of The NVPO is located in the Office of submitted as described in the
the HHS Assistant Secretary for Public ADDRESSES section below no later than
pmangrum on DSK3GDR082PROD with NOTICES
the Assistant Secretary for Health
Affairs; (22) coordinates, develops, (ASH), Office of the Secretary (OS), U.S. midnight, 12:00 a.m. EDT on January 25,
researches, and prepares briefing Department of Health and Human 2017.
materials on issues of adolescent health. Services (HHS). The NVPO is ADDRESSES: Information from
II. Delegations of Authority. Directives responsible for coordinating and Organizations Utilizing Business
or orders made by the Secretary, ensuring collaboration among the many Models Supporting Private Sector
Assistant Secretary for Health, or federal agencies involved in vaccine and Vaccine Management responsive to this
Director, Office of Adolescent Health, immunization activities. RFI should be submitted in Portable
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![Federal Register / Vol. 82, No. 6 / Tuesday, January 10, 2017 / Notices 3007
Document Format (PDF) only and be for patients served by participating Register (81 FR 48437) on July 25, 2016,
submitted via email to nvpo@hhs.gov. practices. and allowed 60 days for public
The name(s) of all PDF files uploaded This request for information is for comment. The IHS received no
should begin with ‘‘NVPO_RFI_ informational purposes only and shall comments regarding this collection. The
MODEL’’ followed by the organization not be construed as a solicitation for purpose of this notice is to allow 30
name and the sequential number of the funding applications/proposals or as days for public comment to be
file, if more than one file is submitted. creating an obligation on the part of the submitted directly to OMB.
All submissions responsive to this RFI government. The government will not A copy of the supporting statement is
must be made as indicated above. pay for the preparation costs of any available at www.regulations.gov (see
Mailed paper submissions will not be information submitted in response to Docket ID IHS–2015–0003).
reviewed. this RFI. Responses to any of the above DATES: February 9, 2017. Your
FOR FURTHER INFORMATION CONTACT: areas are welcome; respondents should comments regarding this information
National Vaccine Program Office, Office not feel compelled to address all the collection are best assured of having full
of the Assistant Secretary for Health, issues identified in the request. effect if received within 30 days of the
Department of Health and Human Responses will be compiled without date of this publication.
Services; telephone (202) 690–5566; company identifiers and shared with ADDRESSES: Send your written
email: nvpo@hhs.gov. HHS Operating Divisions (e.g., the comments, requests for more
SUPPLEMENTARY INFORMATION: Responses
Centers for Disease Control and information on the collection, or
to this RFI should include the Prevention) and advisory committees as requests to obtain a copy of the data
organization’s full name and appropriate. Public release of the data collection instrument and instructions
headquarters location. They should also submitted is governed by the Freedom to Ms. Celeste Davis by one of the
include the name of a point-of-contact of Information Act (https:// following methods:
and his/her email and conventional www.hhs.gov/foia/). Response to the RFI • Mail: Ms. Holly Thompson Duffy,
mailing addresses. Companies are will not be returned. Environmental Protection Specialist,
Information collection sponsored by Division of Environmental Health
invited to respond to the following
the NVPO required for the purposes of Services/Emergency Management
request for information:
informing the National Vaccine Program Coordinator, U.S. DHHS/Indian Health
1. Description of the business model,
and the National Vaccine Plan is not Service, 1414 NW Northrup St., 800,
existing, under development or
subject to Chapter 35 of title 44, United Portland, OR 97209.
planned, and how it addresses any of
the following:
States Code [the Paperwork Reduction • Phone: 509–455–3539.
a. Purchase of vaccines for privately- Act] as indicated in 42 U.S.C. 300aa–1 • Email: Holly.Thompsonduffy@
insured/private pay patients note (section 321 of Pub. L. 99–660). ihs.gov.
b. Bill private insurers for vaccines Dated: January 4, 2017. • Fax: 503–414–7776.
and vaccine administration Roula K. Sweis, SUPPLEMENTARY INFORMATION: The
c. Proper storage and handling of Chief of Operations and Management, Indian Health Service is submitting the
privately-purchased vaccines National Vaccine Program Office. proposed information collection to OMB
d. Management of private vaccine [FR Doc. 2017–00245 Filed 1–9–17; 8:45 am] for review, as required by section
inventories separate from public vaccine BILLING CODE 4150–44–P 3507(a)(1)(D) of the Paperwork
inventories Reduction Act of 1995. This notice is
e. Report vaccine administration to soliciting comments from members of
IIS, including models for populating IIS DEPARTMENT OF HEALTH AND the public and affected agencies as
directly/automatically from EHRs HUMAN SERVICES required by 44 U.S.C. 3506(c)(2)(A)
f. Forecast vaccine demand concerning the proposed collection of
g. Quality improvement efforts to Indian Health Service information to: (1) Evaluate whether the
improve vaccination coverage proposed collection of information is
h. Ability to conduct mass Request for Public Comment: 30 Day necessary for the proper performance of
vaccination clinics as part of an Proposed Information Collection: the functions of the agency, including
emergency response Environmental Health Assessment of whether the information will have
i. Implementation of vaccination as Tribal Child Care Centers in the Pacific practical utility; (2) Evaluate the
part of occupational health clinics Northwest accuracy of the agency’s estimate of the
(including federally-sponsored Indian Health Service, HHS.
AGENCY: burden of the proposed collection of
occupational health clinics). Notice and request for
ACTION: information; (3) Enhance the quality,
2. Description of the practices served, comments. utility, and clarity of the information to
or planned to be served, including be collected; and (4) Minimize the
geographic locations, patients served SUMMARY: In compliance with the burden of the collection of information
(e.g., pediatrics, specialists, health care Paperwork Reduction Act of 1995, the on those who are to respond; including
providers serving adults, etc.), and Indian Health Service (IHS) is through the use of appropriate
practice types (e.g., large health system, submitting to the Office of Management automated collection techniques of
private practices, group practices, etc.). and Budget (OMB) a request for an other forms of information technology,
3. Summary of any evaluations of the extension of a previously approved e.g., permitting electronic submission of
pmangrum on DSK3GDR082PROD with NOTICES
business model’s effectiveness in collection of information titled, ‘‘Indian responses.
expanding accessibility to vaccines for Health Service Environmental Health Title of Proposal: Environmental
privately-insured patients to new groups Assessment of Tribal Child Care Centers Health Assessment of Tribal Child Care
of health care providers who did not in the Pacific Northwest’’ (OMB Control Centers in the Pacific Northwest.
previously provide immunizations or to Number 0917–NEW), which expired OMB Control Number: To be assigned.
existing health care providers to expand September 23, 2016. This proposed Need for the Information and
their immunization services and/or information collection project was Proposed Use: The Portland Area Indian
improvements in vaccination coverage recently published in the Federal Health Service (IHS) and Environmental
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Document Created: 2018-02-01 14:54:15
Document Modified: 2018-02-01 14:54:15
| 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 | Information from Organizations Utilizing Business Models Supporting Private Sector Vaccine Management responsive to this RFI | |
| Contact | National Vaccine Program Office, Office of the Assistant Secretary for Health, Department of Health and Human Services; telephone (202) 690-5566; email: [email protected] | |
| FR Citation | 82 FR 3006 |
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