Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Countermeasures Injury Compensation Program-OMB No. 0915-0334-Extension, 358-360 [2022-28573]

Download as PDF 358 Federal Register / Vol. 88, No. 2 / Wednesday, January 4, 2023 / Notices khammond on DSKJM1Z7X2PROD with NOTICES response, propose criteria for reviewing Healthy Start grant applications with overlapping geographic areas. (3) Provide recommendations on implementing Healthy Start programs with rural populations and underserved populations experiencing disproportionate adverse maternal and infant health outcomes (e.g., American Indian/Alaskan Native). In your response, describe whether potential Healthy Start applicants would benefit from the ability to apply for tiered funding (i.e., flexibility to serve fewer participants for programs with small numbers of residents within their catchment area). (4) Provide recommendations on the most effective period to enroll Healthy Start participants (i.e., pre-conception, prenatal, postpartum) and how long services should be offered to have the greatest impact on improving maternal and infant health outcomes. (5) Provide input on the engagement of fathers in Healthy Start programs and recommendations for types of activities and programming. When possible, provide examples of successful community-based fatherhood initiatives (non-Healthy Start examples are welcome). (6) Provide recommendations for increasing retention of community health workers in Healthy Start programs. (7) Provide recommendations on culturally responsive approaches for providing Black, American Indian, Alaskan Native, and border populations with maternal and child health education, support navigating resources, and linkages to clinical services including doula, prenatal, well-woman, and pediatric care. (8) Provide recommendations for strengthening engagement of birthing people, fathers, families, and people with lived experience in Healthy Start program design, implementation, and evaluation. Data and Evaluation of Healthy Start Programs (9) Provide recommendations on the relevance of the current Healthy Start measures pertaining to the key challenges and inequities experienced in your community and priority population: (a) Which current measures are useful for evaluating program impact and why? (b) Which current measures are not useful for evaluating program impact and why? (c) Are there additional/new measures that would support Healthy Start program evaluation (if applicable provide examples and a rationale)? (For a list of current Healthy Start measures, see page VerDate Sep<11>2014 16:55 Jan 03, 2023 Jkt 259001 20 of the Healthy Start Initiative: Eliminating Disparities in Perinatal Health Notice of Funding Opportunity at https://grants.hrsa.gov/2010/ Web2External/Interface/Common/ EHBDisplayAttachment.aspx?dm_ rtc=16&dm_attid=d3c378a4-b07d-48e5ab36-38f05a7eeb48). (10) HRSA currently provides an optional Healthy Start database to grantees (i.e., CAREWare) https:// healthystartepic.org/healthy-startimplementation/careware-for-healthystart/) free of charge. Provide input on the essential and preferred components of an ideal Healthy Start data system. Would there be an advantage to having one system that all grantees are required to use? Would there be any disadvantages? Respondents may also provide additional comments or recommendations that are not specifically linked to the questions above. All responses may, but are not required to, identify the individual’s name, address, email, telephone number, professional or organizational affiliation, background, or area of expertise (e.g., program participant, family member, clinician, community health worker, researcher, Healthy Start Director, etc.), and topic/subject matter. Information obtained as a result of this RFI may be used by HRSA on a nonattribution basis for program planning. Comments in response to this RFI may be made publicly available, so respondents should bear this in mind when making comments. HRSA will not respond to any individual comments. Special Note to Commenters Whenever possible, respondents are asked to draw their responses from lived experience and/or objective, empirical, and actionable evidence and to cite this evidence within their responses. This RFI is issued solely for information and planning purposes; it does not constitute a Request for Proposal, applications, proposal abstracts, or quotations. This RFI does not commit the government to contract for any supplies or services or make a grant or cooperative agreement award. Further, HRSA is not seeking proposals through this RFI and will not accept unsolicited proposals. HRSA will not respond to questions about the policy issues raised in this RFI. Responders are advised that the U.S. government will not pay for any information or administrative costs incurred in response to this RFI; all costs associated with responding to this RFI will be solely at the interested party’s expense. Not responding to this RFI does not preclude participation in PO 00000 Frm 00021 Fmt 4703 Sfmt 4703 any future procurement or program, if conducted. Diana Espinosa, Deputy Administrator. [FR Doc. 2022–28559 Filed 1–3–23; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Countermeasures Injury Compensation Program—OMB No. 0915–0334—Extension Health Resources and Services Administration (HRSA), Department of Health and Human Services. ACTION: Notice. AGENCY: In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR. DATES: Comments on this ICR should be received no later than March 6, 2023. ADDRESSES: Submit your comments to paperwork@hrsa.gov or by mail to the HRSA Information Collection Clearance Officer, Room 14N39, 5600 Fishers Lane, Rockville, Maryland 20857. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email paperwork@hrsa.gov or call Samantha Miller, the HRSA Information Collection Clearance Officer at (301) 443–1984. SUPPLEMENTARY INFORMATION: When submitting comments or requesting information, please include the ICR title for reference. Information Collection Request Title: Countermeasures Injury Compensation Program—OMB No. 0915–0334— Extension Abstract: This is a request for continued OMB approval of the information collection requirements for the Countermeasures Injury Compensation Program (CICP or Program). The CICP, within the Division SUMMARY: E:\FR\FM\04JAN1.SGM 04JAN1 359 Federal Register / Vol. 88, No. 2 / Wednesday, January 4, 2023 / Notices of Injury Compensation Programs, Health Systems Bureau, HRSA, administers this compensation program as specified by the Public Readiness and Emergency Preparedness Act (PREP Act). CICP is requesting continued approval for this information collection which includes documents specified in the CICP’s regulations (42 CFR part 110). The PREP Act created the CICP and provides liability immunity to covered persons for claims of loss caused by, arising out of, relating to, or resulting from the administration or use of covered countermeasures for diseases, threats, and conditions identified in PREP Act declarations. The immunity extended in the PREP Act encourages the development, manufacture, testing, distribution, and administration/use of countermeasures (e.g., vaccine, medication, device) when a disease, health condition, or other threat to health constitutes a public health emergency, or there is a credible risk that it may in the future constitute such an emergency. Need and Proposed Use of the Information: CICP provides compensation to eligible individuals who suffer serious injuries or death directly caused by a covered countermeasure administered or used pursuant to a PREP Act Declaration or their estates and/or to certain survivors. An individual who is an injured countermeasure recipient, the individual’s legal representative, or the estate or survivor(s) of an injured countermeasure recipient is responsible for submitting the Request for Benefits (RFB) package, as well as the injured countermeasure recipient’s medical records and supporting documentation. Individuals are able to apply at any time, but eligibility for compensation is subject to meeting applicable filing deadlines and other requirements. To determine whether a requester is eligible for Program benefits (compensation) for a countermeasure injury, CICP staff must review the RFB package which includes the following: (1) RFB Form and Supporting Documentation The RFB Form and supporting documentation initiate the CICP claims review process. They also serve as the CICP’s mechanism for gathering required information about the requester, documenting the use or administration of a countermeasure, and obtaining medical information about the countermeasure recipient. (2) Authorization for Use or Disclosure of Health Information Form The Authorization Form is completed by the requester and gives medical providers permission to disclose the countermeasure recipient’s health information via medical records to CICP for the purpose of determining eligibility for CICP benefits. (3) Additional Documentation and Certification During the eligibility review, CICP provides requesters with the opportunity to supplement their RFB with additional medical records and supporting documentation before the Program makes a final decision. CICP asks requesters to complete and sign a form indicating whether they intend to submit additional documentation prior to the final determination of their case. After CICP makes a final decision on a case, there are no other opportunities for a requester to submit additional medical records or supporting documents. (4) Benefits Package and Supporting Documentation A requester who is an injured countermeasure recipient may be eligible to receive benefits for unreimbursed medical expenses and/or lost employment income. The estate of a deceased countermeasure recipient may also be eligible to receive payment for unreimbursed medical expenses and/or lost employment income accrued prior to the injured countermeasure recipient’s death. These documents ask the requester to submit documentation of the countermeasure recipient’s unreimbursed medical expenses and lost employment income. If death was the result of the administration or use of the countermeasure, certain survivor(s) of eligible deceased countermeasure recipients may be eligible to receive a death benefit, but not unreimbursed medical expenses or lost employment income benefits (42 CFR 110.33). These documents request additional information, such as a marriage license, from the requester to prove that they are a survivor of the deceased countermeasure recipient. The RFB that CICP sends to requesters who may be eligible for compensation includes certification forms and instructions outlining the supporting documentation needed to determine the type and amount of benefits. This documentation is required under 42 CFR 110.60–110.63 of CICP’s implementing regulation to enable the Program to determine the type and amount of benefits the requester may be eligible to receive. Likely Respondents: Countermeasure claimants are the most likely respondents to this Federal Register notice regarding the CICP information collection request because CICP reviews and, if eligible, compensates countermeasure recipient injury claims. Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose, or provide the information requested. This includes the time needed to review instructions; to develop, acquire, install, and utilize technology and systems for the purpose of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information; to search data sources; to complete and review the collection of information; and to transmit or otherwise disclose the information. The total annual burden hours estimated for this ICR are summarized in the table below. TOTAL ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents khammond on DSKJM1Z7X2PROD with NOTICES Form name Number of responses per respondent Total responses Average burden per response (in hours) Total burden hours Request for Benefits Form and Supporting Documentation Authorization for Use or Disclosure of Health Information Form ................................................................................. Additional Documentation and Certification ......................... Benefits Package and Supporting Documentation .............. 100 1 100 11.000 1,100.00 100 30 30 1 1 1 100 30 30 2.000 0.750 0.125 200.00 22.50 3.75 Total .............................................................................. 260 ........................ 260 ........................ 1,326.25 VerDate Sep<11>2014 16:55 Jan 03, 2023 Jkt 259001 PO 00000 Frm 00022 Fmt 4703 Sfmt 4703 E:\FR\FM\04JAN1.SGM 04JAN1 360 Federal Register / Vol. 88, No. 2 / Wednesday, January 4, 2023 / Notices HRSA specifically requests comments on (1) the necessity and utility of the proposed information collection for the proper performance of the agency’s functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. Maria G. Button, Director, Executive Secretariat. [FR Doc. 2022–28573 Filed 1–3–23; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Public Comment Request; Shortage Designation Management System Health Resources and Services Administration (HRSA), Department of Health and Human Services. ACTION: Notice. AGENCY: In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR. DATES: Comments on this ICR should be received no later than March 6, 2023. ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail to: Samantha Miller, HRSA Information Collection Clearance Officer, Room 14N39, 5600 Fishers Lane, Rockville, Maryland 20857. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email paperwork@hrsa.gov or call Samantha Miller, the acting HRSA Information Collection Clearance Officer at (301) 594–4394. SUPPLEMENTARY INFORMATION: When submitting comments or requesting information, please include the information request collection title for reference. khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 16:55 Jan 03, 2023 Jkt 259001 Information Collection Request Title: Shortage Designation Management System OMB No. 0906–0029— Extension. Abstract: HRSA is committed to improving the health of the nation’s underserved communities and vulnerable populations by developing, implementing, evaluating, and refining programs that strengthen the nation’s health workforce. The Department of Health and Human Services relies on two federal shortage designations to identify and dedicate resources to areas and populations in greatest need of providers: Health Professional Shortage Area (HPSA) designations and Medically Underserved Area/Medically Underserved Population (MUA/P) designations. HPSA designations are geographic areas, population groups, and facilities that are experiencing a shortage of health professionals. The authorizing statute for the National Health Service Corps (NHSC) created HPSAs to fulfill the statutory requirement that NHSC personnel be directed to areas of greatest need. To further differentiate areas of greatest need, HRSA calculates a score for each HPSA. There are three categories of HPSAs based on health discipline: primary care, dental health, and mental health. Scores range from 1 to 25 for primary care and mental health and from 1 to 26 for dental, with higher scores indicating greater need. HRSA uses these scores to prioritize applications for NHSC Loan Repayment Program award funding, and determine service sites eligible to receive NHSC Scholarship and Students-to-Service participants. MUA/P designations are geographic areas, or population groups within geographic areas, that are experiencing a shortage of primary care health care services based on the Index of Medical Underservice. MUAs are designated for the entire population of a particular geographic area. MUA/P designations are limited to particular subset of the population within a geographic area. Both designations were created to aid the federal government in identifying areas with healthcare workforce shortages. As part of HRSA’s cooperative agreement with the state Primary Care Offices (PCOs), the PCOs conduct needs assessment in their states, determine what areas are eligible for designations, and submit designation applications for HRSA review via the Shortage Designation Management System (SDMS). Requests that come from other sources are referred to the PCOs for their review, concurrence, and submission via SDMS. To obtain a federal shortage PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 designation for an area, population, or facility, PCOs must submit a shortage designation application through SDMS for HRSA’s review and approval. Both the HPSA and MUA/P application request local, state, and national data on the population that is experiencing a shortage of health professionals and the number of health professionals relative to the population covered by the proposed designation. HRSA uses the information collected on the applications to determine which areas, populations, and facilities have qualifying shortages. In addition, HRSA notifies interested parties, including the governor, the state primary care association, state professional associations, etc., of each designation request submitted via SDMS for their comments and recommendations. HRSA reviews the HPSA applications submitted by the PCOs, and—if they meet the designation eligibility criteria—designates the HPSA or MUA/ P on behalf of the Secretary. HPSAs are statutorily required to be annually reviewed and revised as necessary after initial designation to reflect current data. HPSA scores, therefore, may and do change from time to time. Currently, MUA/Ps do not have a statutorily mandated review period. The lists of designated HPSAs are published annually in the Federal Register. In addition, lists of HPSAs are updated on the HRSA website, https:// data.hrsa.gov/tools/shortage-area. Need and Proposed Use of the Information: In 2014, SDMS was launched to facilitate the collection of information needed to designate HPSAs and MUA/Ps. The information obtained from the SDMS application is used to determine which areas, populations, and facilities have critical shortages of health professionals per PCO application submission. The SDMS HPSA application and SDMS MUA/P application are used for these designation determinations. Applicants must submit a SDMS application to HRSA to obtain a federal shortage designation. The application asks for local, state, and national data required to determine the application’s eligibility to obtain a federal shortage designation. In addition, applicants must enter detailed information explaining how the area, population, or facility faces a critical shortage of health professionals. Likely Respondents: PCOs interested in obtaining a primary care, dental, or mental HPSA designation or a MUA/P in their state. Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, E:\FR\FM\04JAN1.SGM 04JAN1

Agencies

[Federal Register Volume 88, Number 2 (Wednesday, January 4, 2023)]
[Notices]
[Pages 358-360]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-28573]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Proposed Collection: 
Public Comment Request; Information Collection Request Title: 
Countermeasures Injury Compensation Program--OMB No. 0915-0334--
Extension

AGENCY: Health Resources and Services Administration (HRSA), Department 
of Health and Human Services.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: In compliance with the requirement for opportunity for public 
comment on proposed data collection projects of the Paperwork Reduction 
Act of 1995, HRSA announces plans to submit an Information Collection 
Request (ICR), described below, to the Office of Management and Budget 
(OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the 
public regarding the burden estimate, below, or any other aspect of the 
ICR.

DATES: Comments on this ICR should be received no later than March 6, 
2023.

ADDRESSES: Submit your comments to [email protected] or by mail to the 
HRSA Information Collection Clearance Officer, Room 14N39, 5600 Fishers 
Lane, Rockville, Maryland 20857.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the data collection plans and 
draft instruments, email [email protected] or call Samantha Miller, 
the HRSA Information Collection Clearance Officer at (301) 443-1984.

SUPPLEMENTARY INFORMATION: When submitting comments or requesting 
information, please include the ICR title for reference.
    Information Collection Request Title: Countermeasures Injury 
Compensation Program--OMB No. 0915-0334--Extension
    Abstract: This is a request for continued OMB approval of the 
information collection requirements for the Countermeasures Injury 
Compensation Program (CICP or Program). The CICP, within the Division

[[Page 359]]

of Injury Compensation Programs, Health Systems Bureau, HRSA, 
administers this compensation program as specified by the Public 
Readiness and Emergency Preparedness Act (PREP Act). CICP is requesting 
continued approval for this information collection which includes 
documents specified in the CICP's regulations (42 CFR part 110).
    The PREP Act created the CICP and provides liability immunity to 
covered persons for claims of loss caused by, arising out of, relating 
to, or resulting from the administration or use of covered 
countermeasures for diseases, threats, and conditions identified in 
PREP Act declarations. The immunity extended in the PREP Act encourages 
the development, manufacture, testing, distribution, and 
administration/use of countermeasures (e.g., vaccine, medication, 
device) when a disease, health condition, or other threat to health 
constitutes a public health emergency, or there is a credible risk that 
it may in the future constitute such an emergency.
    Need and Proposed Use of the Information: CICP provides 
compensation to eligible individuals who suffer serious injuries or 
death directly caused by a covered countermeasure administered or used 
pursuant to a PREP Act Declaration or their estates and/or to certain 
survivors. An individual who is an injured countermeasure recipient, 
the individual's legal representative, or the estate or survivor(s) of 
an injured countermeasure recipient is responsible for submitting the 
Request for Benefits (RFB) package, as well as the injured 
countermeasure recipient's medical records and supporting 
documentation. Individuals are able to apply at any time, but 
eligibility for compensation is subject to meeting applicable filing 
deadlines and other requirements.
    To determine whether a requester is eligible for Program benefits 
(compensation) for a countermeasure injury, CICP staff must review the 
RFB package which includes the following:
(1) RFB Form and Supporting Documentation
    The RFB Form and supporting documentation initiate the CICP claims 
review process. They also serve as the CICP's mechanism for gathering 
required information about the requester, documenting the use or 
administration of a countermeasure, and obtaining medical information 
about the countermeasure recipient.
(2) Authorization for Use or Disclosure of Health Information Form
    The Authorization Form is completed by the requester and gives 
medical providers permission to disclose the countermeasure recipient's 
health information via medical records to CICP for the purpose of 
determining eligibility for CICP benefits.
(3) Additional Documentation and Certification
    During the eligibility review, CICP provides requesters with the 
opportunity to supplement their RFB with additional medical records and 
supporting documentation before the Program makes a final decision. 
CICP asks requesters to complete and sign a form indicating whether 
they intend to submit additional documentation prior to the final 
determination of their case. After CICP makes a final decision on a 
case, there are no other opportunities for a requester to submit 
additional medical records or supporting documents.
(4) Benefits Package and Supporting Documentation
    A requester who is an injured countermeasure recipient may be 
eligible to receive benefits for unreimbursed medical expenses and/or 
lost employment income. The estate of a deceased countermeasure 
recipient may also be eligible to receive payment for unreimbursed 
medical expenses and/or lost employment income accrued prior to the 
injured countermeasure recipient's death. These documents ask the 
requester to submit documentation of the countermeasure recipient's 
unreimbursed medical expenses and lost employment income. If death was 
the result of the administration or use of the countermeasure, certain 
survivor(s) of eligible deceased countermeasure recipients may be 
eligible to receive a death benefit, but not unreimbursed medical 
expenses or lost employment income benefits (42 CFR 110.33). These 
documents request additional information, such as a marriage license, 
from the requester to prove that they are a survivor of the deceased 
countermeasure recipient.
    The RFB that CICP sends to requesters who may be eligible for 
compensation includes certification forms and instructions outlining 
the supporting documentation needed to determine the type and amount of 
benefits. This documentation is required under 42 CFR 110.60-110.63 of 
CICP's implementing regulation to enable the Program to determine the 
type and amount of benefits the requester may be eligible to receive.
    Likely Respondents: Countermeasure claimants are the most likely 
respondents to this Federal Register notice regarding the CICP 
information collection request because CICP reviews and, if eligible, 
compensates countermeasure recipient injury claims.
    Burden Statement: Burden in this context means the time expended by 
persons to generate, maintain, retain, disclose, or provide the 
information requested. This includes the time needed to review 
instructions; to develop, acquire, install, and utilize technology and 
systems for the purpose of collecting, validating, and verifying 
information, processing and maintaining information, and disclosing and 
providing information; to train personnel and to be able to respond to 
a collection of information; to search data sources; to complete and 
review the collection of information; and to transmit or otherwise 
disclose the information. The total annual burden hours estimated for 
this ICR are summarized in the table below.

                                     Total Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
            Form name                Number of     responses per       Total       per response    Total burden
                                    respondents     respondent       responses      (in hours)         hours
----------------------------------------------------------------------------------------------------------------
Request for Benefits Form and                100               1             100          11.000        1,100.00
 Supporting Documentation.......
Authorization for Use or                     100               1             100           2.000          200.00
 Disclosure of Health
 Information Form...............
Additional Documentation and                  30               1              30           0.750           22.50
 Certification..................
Benefits Package and Supporting               30               1              30           0.125            3.75
 Documentation..................
                                 -------------------------------------------------------------------------------
    Total.......................             260  ..............             260  ..............        1,326.25
----------------------------------------------------------------------------------------------------------------


[[Page 360]]

    HRSA specifically requests comments on (1) the necessity and 
utility of the proposed information collection for the proper 
performance of the agency's functions; (2) the accuracy of the 
estimated burden; (3) ways to enhance the quality, utility, and clarity 
of the information to be collected; and (4) the use of automated 
collection techniques or other forms of information technology to 
minimize the information collection burden.

Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2022-28573 Filed 1-3-23; 8:45 am]
BILLING CODE 4165-15-P


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