81_FR_43342 81 FR 43215 - Agency Information Collection Activities: Proposed Collection: Comment Request [email protected] or call the HRSA Information Collection Clearance Officer at (301) 443- 1984."> [email protected] or call the HRSA Information Collection Clearance Officer at (301) 443- 1984." /> [email protected] or call the HRSA Information Collection Clearance Officer at (301) 443- 1984." />

81 FR 43215 - Agency Information Collection Activities: Proposed Collection: Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration

Federal Register Volume 81, Issue 127 (July 1, 2016)

Page Range43215-43216
FR Document2016-15710

In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 104-13), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. 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 the HRSA Information Collection Clearance Officer at (301) 443- 1984.

Federal Register, Volume 81 Issue 127 (Friday, July 1, 2016)
[Federal Register Volume 81, Number 127 (Friday, July 1, 2016)]
[Notices]
[Pages 43215-43216]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-15710]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Proposed Collection: 
Comment Request

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Notice.

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

SUMMARY: In compliance with the requirement for opportunity for public 
comment on proposed data collection projects (Section 3506(c)(2)(A) of 
Title 44, United States Code, as amended by the Paperwork Reduction Act 
of 1995, Pub. L. 104-13), the Health Resources and Services 
Administration (HRSA) publishes periodic summaries of proposed projects 
being developed for submission to the Office of Management and Budget 
(OMB) under the Paperwork Reduction Act of 1995. 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 the HRSA Information Collection Clearance Officer at (301) 443-
1984.

DATES: Comments on this ICR should be received no later than August 30, 
2016.

ADDRESSES: Submit your comments to [email protected] or by mail to the 
HRSA Reports Clearance Officer, 14N39, 5600 Fishers Lane, Rockville, MD 
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 the HRSA 
Information Collection Clearance Officer at (301) 443-1984.

SUPPLEMENTARY INFORMATION: When submitting comments or requesting 
information, please include the information request collection title 
for reference.
    Information Collection Request Title: Countermeasures Injury 
Compensation Program.
    OMB No. 0915-0334--Extension.
    Abstract: This is an extension request for OMB approval of the 
information collection requirements for the Countermeasures Injury 
Compensation Program (CICP or Program). CICP, within the Division of 
Injury Compensation Programs (DICP), Healthcare Systems Bureau, HRSA, 
administers the compensation program specified by the Public Readiness 
and Emergency Preparedness Act of 2005 (PREP Act). CICP provides 
compensation to eligible individuals who suffer serious injuries 
directly caused by a covered countermeasure administered or used 
pursuant to a PREP Act Declaration, or to their estates and/or to 
certain survivors. A declaration is issued by the Secretary of the 
Department of Health and Humans Services (Secretary). The purpose of a 
declaration is to identify a disease, health condition, or a threat to 
health that is currently, or may in the future constitute, a public 
health emergency. In addition, the Secretary, through a declaration, 
may recommend and encourage the development, manufacturing, 
distribution, dispensing, and administration or use of one or more 
covered countermeasures to treat, prevent, or diagnose the disease, 
condition, or threat specified in the declaration.
    To determine whether a requester is eligible for Program benefits 
(compensation) for the injury, CICP must review the Request for 
Benefits Package, which includes the Request for Benefits Form and 
Authorization for

[[Page 43216]]

Use or Disclosure of Health Information Form(s), as well as the injured 
countermeasure recipient's medical records 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 medical benefits and/or 
benefits for lost employment income accrued prior to the injured 
countermeasure recipient's death. If death was the result of the 
administration or use of the countermeasure, certain survivor(s) of 
deceased eligible countermeasure recipients may be eligible to receive 
a death benefit, but not unreimbursed medical expenses or lost 
employment income benefits. 42 CFR 110.33. The death benefit is 
calculated using either the ``standard calculation'' or the 
``alternative calculation.'' The ``standard calculation'' is based on 
the death benefit available under the Public Safety Officers' Benefits 
(PSOB) Program. 42 CFR 110.82(b). The ``alternative calculation'' is 
based on the deceased countermeasure recipient's income and is only 
available to the recipient's dependent(s) younger than age 18 at the 
time of the countermeasure recipient's death. Continued approval is 
requested for the required information collection via the Request for 
Benefits Package (RFB) and for continued use of CICP's mechanisms of 
medical documentation and supporting documentation collection. During 
the eligibility review, CICP provides requesters with the opportunity 
to supplement their Requests for Benefits with additional medical 
records and supporting documentation before a final Program decision is 
made. 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. In addition, approval is requested 
for the continued use of a benefits documentation package that CICP 
sends to requesters who may be eligible for compensation, which 
includes certification forms and instructions outlining the 
documentation needed to determine the types and amounts of benefits. 
This documentation is required under 42 CFR 110.61-110.63 of CICP's 
implementing regulation to enable the Program to determine the types 
and amounts of benefits the requester may be eligible to receive. 
Likely Respondents: Members of the public who believe they have 
sustained serious physical injuries or deaths as the direct result of 
the administration or use of a covered countermeasure for a disease, 
condition, or threat that the Secretary determines either constitutes a 
current public health emergency, or there is a credible risk that the 
disease, condition, or threat may in the future constitute such an 
emergency. Persons who may be eligible to receive benefits from the 
CICP are:
    (1) Injured countermeasure recipients, as described in Sec.  
110.3(n).
    (2) Survivors, as described in Sec. Sec.  110.3(cc) and 110.11.
    (3) Estates of deceased injured countermeasure recipients, as 
described in Sec.  110.10(a)(3).
    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 Information Collection Request are summarized in the table below.
    The annual estimate of burden is as follows:

----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                     Number of       Number of         Total        burden per     Total burden
            Form name               respondents    responses per     responses     response  (in       hours
                                                    respondent                        hours)
----------------------------------------------------------------------------------------------------------------
Request for Benefits Form and                100               1             100              11           1,100
 Supporting Documentation.......
Authorization for Use or                     100               1             100               2             200
 Disclosure of Health
 Information Form...............
Additional Documentation and                  30               1              30             .75            22.5
 Certification..................
Benefits Package and Supporting               30               1              30            .125            3.75
 Documentation..................
                                 -------------------------------------------------------------------------------
    Total.......................             100  ..............             100  ..............        1,326.25
----------------------------------------------------------------------------------------------------------------
* The number 100 represents an estimate of individuals applying for Program benefits. The 4 documents are
  required of the same 100 individuals or subset of the 100 individuals.

    HRSA especially 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.

Jason E. Bennett,
Director, Division of the Executive Secretariat.
[FR Doc. 2016-15710 Filed 6-30-16; 8:45 am]
 BILLING CODE 4165-15-P



                                                                                      Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Notices                                          43215

                                                    No. 126/Wednesday, July 1, 2015/                        may have been designated by letter                     to obtain a copy of the data collection
                                                    Notices 37637). The lists also include                  since that date. The appropriate                       plans and draft instruments, email
                                                    automatic facility HPSAs, designated as                 agencies and individuals have been or                  paperwork@hrsa.gov or call the HRSA
                                                    a result of the Health Care Safety Net                  will be notified of these actions by                   Information Collection Clearance Officer
                                                    Amendments of 2002 (Pub. L. 107–251),                   letter. These newly designated HPSAs                   at (301) 443–1984.
                                                    not subject to update requirements.                     will be included in the next publication               DATES: Comments on this ICR should be
                                                    Each list of designated HPSAs (primary                  of the HPSA list and are currently                     received no later than August 30, 2016.
                                                    medical care, mental health, and dental)                included in the daily updates posted on                ADDRESSES: Submit your comments to
                                                    is arranged by state. Within each state,                the HRSA Web site at http://                           paperwork@hrsa.gov or by mail to the
                                                    the list is presented by county. If only                www.hrsa.gov/shortage/find.html.                       HRSA Reports Clearance Officer, 14N39,
                                                    a portion (or portions) of a county is                     Any designated HPSA listed on the                   5600 Fishers Lane, Rockville, MD
                                                    (are) designated, or if the county is part              HRSA Web site is subject to withdrawal                 20857.
                                                    of a larger designated service area, or if              from designation if new information
                                                                                                                                                                   FOR FURTHER INFORMATION CONTACT: To
                                                    a population group residing in the                      received and confirmed by HRSA
                                                    county or a facility located in the county                                                                     request more information on the
                                                                                                            indicates that the relevant data for the
                                                    has been designated, the name of the                                                                           proposed project or to obtain a copy of
                                                                                                            area involved have significantly
                                                    service area, population group, or                                                                             the data collection plans and draft
                                                                                                            changed since its designation. The
                                                    facility involved is listed under the                                                                          instruments, email paperwork@hrsa.gov
                                                                                                            effective date of such a withdrawal will
                                                    county name. Counties that have a                                                                              or call the HRSA Information Collection
                                                                                                            be the next publication of a notice
                                                    whole county geographic HPSA are                                                                               Clearance Officer at (301) 443–1984.
                                                                                                            regarding this list in the Federal
                                                    indicated by the ‘‘Entire county HPSA’’                                                                        SUPPLEMENTARY INFORMATION: When
                                                                                                            Register.
                                                    notation following the county name.                        All requests for new designations,                  submitting comments or requesting
                                                    Further details on the snapshot of                      updates, or withdrawals should be                      information, please include the
                                                    HPSAs listed can be found on the HRSA                   based on the relevant criteria in                      information request collection title for
                                                    Web site: http://www.hrsa.gov/                          regulations published at 42 CFR part 5.                reference.
                                                    shortage/.                                                                                                        Information Collection Request Title:
                                                       In addition to the specific listings                 Electronic Access Address                              Countermeasures Injury Compensation
                                                    included in this notice, all Indian Tribes                The complete list of HPSAs                           Program.
                                                    that meet the definition of such Tribes                 designated as of May 13, 2016, are                        OMB No. 0915–0334—Extension.
                                                    in the Indian Health Care Improvement                   available on the HRSA Web site at                         Abstract: This is an extension request
                                                    Act of 1976, 25 U.S.C. 1603(d), are                     http://www.hrsa.gov/shortage/.                         for OMB approval of the information
                                                    automatically designated as population                  Frequently updated information on                      collection requirements for the
                                                    groups with primary medical care and                    HPSAs is also available at http://                     Countermeasures Injury Compensation
                                                    dental health professional shortages.                   datawarehouse.hrsa.gov.                                Program (CICP or Program). CICP,
                                                    The Health Care Safety Net                                                                                     within the Division of Injury
                                                                                                              Dated: June 24, 2016.                                Compensation Programs (DICP),
                                                    Amendments of 2002 also made the
                                                                                                            James Macrae,                                          Healthcare Systems Bureau, HRSA,
                                                    following entities eligible for automatic
                                                    facility HPSA designations: All federally               Acting Administrator.                                  administers the compensation program
                                                    qualified health centers (FQHCs) and                    [FR Doc. 2016–15678 Filed 6–30–16; 8:45 am]            specified by the Public Readiness and
                                                    rural health clinics that offer services                BILLING CODE 4165–15–P                                 Emergency Preparedness Act of 2005
                                                    regardless of ability to pay. These                                                                            (PREP Act). CICP provides
                                                    entities include: FQHCs funded under                                                                           compensation to eligible individuals
                                                    section 330 of the PHS Act, FQHC Look-                  DEPARTMENT OF HEALTH AND                               who suffer serious injuries directly
                                                    Alikes, and Tribal and urban Indian                     HUMAN SERVICES                                         caused by a covered countermeasure
                                                    clinics operating under the Indian Self-                                                                       administered or used pursuant to a
                                                    Determination and Education Act of                      Health Resources and Services                          PREP Act Declaration, or to their estates
                                                    1975 (25 U.S.C. 450) or the Indian                      Administration                                         and/or to certain survivors. A
                                                    Health Care Improvement Act. Many,                                                                             declaration is issued by the Secretary of
                                                                                                            Agency Information Collection                          the Department of Health and Humans
                                                    but not all, of these entities are included             Activities: Proposed Collection:
                                                    on this listing. Exclusion from this list                                                                      Services (Secretary). The purpose of a
                                                                                                            Comment Request                                        declaration is to identify a disease,
                                                    does not exclude them from HPSA
                                                    designation; any facilities eligible for                AGENCY: Health Resources and Services                  health condition, or a threat to health
                                                    automatic designation will be included                  Administration, HHS.                                   that is currently, or may in the future
                                                    in the HRSA Data Warehouse list of                      ACTION: Notice.                                        constitute, a public health emergency.
                                                    HPSAs as they are identified.                                                                                  In addition, the Secretary, through a
                                                                                                            SUMMARY:   In compliance with the                      declaration, may recommend and
                                                    Future Updates of Lists of Designated                   requirement for opportunity for public                 encourage the development,
                                                    HPSAs                                                   comment on proposed data collection                    manufacturing, distribution, dispensing,
                                                      The lists of HPSAs at http://                         projects (Section 3506(c)(2)(A) of Title               and administration or use of one or
                                                    www.hrsa.gov/shortage/ consist of all                   44, United States Code, as amended by                  more covered countermeasures to treat,
                                                    those that were designated as of May 13,                the Paperwork Reduction Act of 1995,                   prevent, or diagnose the disease,
asabaliauskas on DSK3SPTVN1PROD with NOTICES




                                                    2016. It should be noted that HPSAs are                 Pub. L. 104–13), the Health Resources                  condition, or threat specified in the
                                                    currently updated on an ongoing basis                   and Services Administration (HRSA)                     declaration.
                                                    based on the identification of new areas,               publishes periodic summaries of                           To determine whether a requester is
                                                    population groups, facilities, and sites                proposed projects being developed for                  eligible for Program benefits
                                                    that meet the eligibility criteria or that              submission to the Office of Management                 (compensation) for the injury, CICP
                                                    no longer meet eligibility criteria and/or              and Budget (OMB) under the Paperwork                   must review the Request for Benefits
                                                    are being replaced by another type of                   Reduction Act of 1995. To request more                 Package, which includes the Request for
                                                    designation. As such, additional HPSAs                  information on the proposed project or                 Benefits Form and Authorization for


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                                                    43216                                        Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Notices

                                                    Use or Disclosure of Health Information                                    via the Request for Benefits Package                           public health emergency, or there is a
                                                    Form(s), as well as the injured                                            (RFB) and for continued use of CICP’s                          credible risk that the disease, condition,
                                                    countermeasure recipient’s medical                                         mechanisms of medical documentation                            or threat may in the future constitute
                                                    records and supporting documentation.                                      and supporting documentation                                   such an emergency. Persons who may
                                                       A requester who is an injured                                           collection. During the eligibility review,                     be eligible to receive benefits from the
                                                    countermeasure recipient may be                                            CICP provides requesters with the                              CICP are:
                                                    eligible to receive benefits for                                           opportunity to supplement their                                   (1) Injured countermeasure recipients,
                                                    unreimbursed medical expenses and/or                                       Requests for Benefits with additional                          as described in § 110.3(n).
                                                    lost employment income. The estate of                                      medical records and supporting                                    (2) Survivors, as described in
                                                    a deceased countermeasure recipient                                        documentation before a final Program                           §§ 110.3(cc) and 110.11.
                                                    may also be eligible to receive medical                                    decision is made. CICP asks requesters                            (3) Estates of deceased injured
                                                    benefits and/or benefits for lost                                          to complete and sign a form indicating                         countermeasure recipients, as described
                                                    employment income accrued prior to                                         whether they intend to submit                                  in § 110.10(a)(3).
                                                    the injured countermeasure recipient’s                                     additional documentation prior to the                             Burden Statement: Burden in this
                                                    death. If death was the result of the                                      final determination of their case. In                          context means the time expended by
                                                    administration or use of the                                               addition, approval is requested for the                        persons to generate, maintain, retain,
                                                    countermeasure, certain survivor(s) of                                     continued use of a benefits                                    disclose or provide the information
                                                    deceased eligible countermeasure                                           documentation package that CICP sends                          requested. This includes the time
                                                    recipients may be eligible to receive a                                    to requesters who may be eligible for                          needed to review instructions; to
                                                    death benefit, but not unreimbursed                                        compensation, which includes                                   develop, acquire, install and utilize
                                                    medical expenses or lost employment                                        certification forms and instructions                           technology and systems for the purpose
                                                    income benefits. 42 CFR 110.33. The                                        outlining the documentation needed to                          of collecting, validating and verifying
                                                    death benefit is calculated using either                                   determine the types and amounts of                             information, processing and
                                                    the ‘‘standard calculation’’ or the                                        benefits. This documentation is required                       maintaining information, and disclosing
                                                    ‘‘alternative calculation.’’ The ‘‘standard                                under 42 CFR 110.61–110.63 of CICP’s                           and providing information; to train
                                                    calculation’’ is based on the death                                        implementing regulation to enable the                          personnel and to be able to respond to
                                                    benefit available under the Public Safety                                  Program to determine the types and                             a collection of information; to search
                                                    Officers’ Benefits (PSOB) Program. 42                                      amounts of benefits the requester may                          data sources; to complete and review
                                                    CFR 110.82(b). The ‘‘alternative                                           be eligible to receive. Likely                                 the collection of information; and to
                                                    calculation’’ is based on the deceased                                     Respondents: Members of the public                             transmit or otherwise disclose the
                                                    countermeasure recipient’s income and                                      who believe they have sustained serious                        information. The total annual burden
                                                    is only available to the recipient’s                                       physical injuries or deaths as the direct                      hours estimated for this Information
                                                    dependent(s) younger than age 18 at the                                    result of the administration or use of a                       Collection Request are summarized in
                                                    time of the countermeasure recipient’s                                     covered countermeasure for a disease,                          the table below.
                                                    death. Continued approval is requested                                     condition, or threat that the Secretary                           The annual estimate of burden is as
                                                    for the required information collection                                    determines either constitutes a current                        follows:

                                                                                                                                                                                                                  Average
                                                                                                                                                                     Number of
                                                                                                                                                  Number of                                      Total          burden per              Total burden
                                                                                       Form name                                                                   responses per
                                                                                                                                                 respondents                                  responses          response                  hours
                                                                                                                                                                     respondent                                  (in hours)

                                                    Request for Benefits Form and Supporting Documentation                                                   100                        1            100                         11            1,100
                                                    Authorization for Use or Disclosure of Health Information
                                                      Form .................................................................................                 100                        1            100                         2                200
                                                    Additional Documentation and Certification .........................                                      30                        1             30                       .75               22.5
                                                    Benefits Package and Supporting Documentation ..............                                              30                        1             30                      .125               3.75

                                                          Total ..............................................................................               100   ........................          100     ........................       1,326.25
                                                      * The number 100 represents an estimate of individuals applying for Program benefits. The 4 documents are required of the same 100 individ-
                                                    uals or subset of the 100 individuals.


                                                      HRSA especially requests comments                                        DEPARTMENT OF HEALTH AND                                       the public interest in connection with
                                                    on: (1) The necessity and utility of the                                   HUMAN SERVICES                                                 the performance of duties imposed on
                                                    proposed information collection for the                                                                                                   the National Institutes of Health by law,
                                                    proper performance of the agency’s                                         National Institutes of Health                                  and that these duties can best be
                                                    functions, (2) the accuracy of the                                                                                                        performed through the advice and
                                                    estimated burden, (3) ways to enhance                                      Office of the Director; Notice of Charter
                                                                                                                                                                                              counsel of this group.
                                                    the quality, utility, and clarity of the                                   Renewal
                                                                                                                                                                                                Inquiries may be directed to Jennifer
                                                    information to be collected, and (4) the
                                                                                                                                 In accordance with Title 41 of the                           Spaeth, Director, Office of Federal
asabaliauskas on DSK3SPTVN1PROD with NOTICES




                                                    use of automated collection techniques
                                                    or other forms of information                                              U.S. Code of Federal Regulations,                              Advisory Committee Policy, Office of
                                                    technology to minimize the information                                     Section 102–3.65(a), notice is hereby                          the Director, National Institutes of
                                                    collection burden.                                                         given that the Charter for the Office of                       Health, 6701 Democracy Boulevard,
                                                                                                                               AIDS Research Advisory Council was                             Suite 1000, Bethesda, Maryland 20892
                                                    Jason E. Bennett,                                                          renewed for an additional two-year                             (Mail code 4875), Telephone (301) 496–
                                                    Director, Division of the Executive Secretariat.                           period on June 27, 2016.                                       2123, or spaethj@od.nih.gov.
                                                    [FR Doc. 2016–15710 Filed 6–30–16; 8:45 am]                                  It is determined that the Office of
                                                    BILLING CODE 4165–15–P                                                     AIDS Research Advisory Council is in


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Document Created: 2016-07-14 11:37:53
Document Modified: 2016-07-14 11:37:53
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesComments on this ICR should be received no later than August 30, 2016.
ContactTo 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 the HRSA Information Collection Clearance Officer at (301) 443-1984.
FR Citation81 FR 43215 

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