Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Countermeasures Injury Compensation Program, 60708-60710 [2016-21168]
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Federal Register / Vol. 81, No. 171 / Friday, September 2, 2016 / Notices
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56469, September 18, 2015, or access
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regulatoryinformation/dockets/
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and Drug Administration, Three White
Flint North, 10A63, 11601 Landsdown
FOR FURTHER INFORMATION CONTACT:
St., North Bethesda, MD 20852,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,]
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Form FDA 3728, Animal Generic User
Fee Act Cover Sheet—21 U.S.C. 379j–21
OMB Control Number 0910–0632—
Extension
Section 741 of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21
U.S.C. 379j–21) establishes three
different kinds of user fees: (1) Fees for
certain types of abbreviated applications
for generic new animal drugs; (2) annual
fees for certain generic new animal drug
products; and (3) annual fees for certain
sponsors of abbreviated applications for
generic new animal drugs and/or
investigational submissions for generic
new animal drugs (21 U.S.C. 379j–
21(a)). Because concurrent submission
of user fees with applications is
required, the review of an application
cannot begin until the fee is submitted.
Form FDA 3728 is the AGDUFA Cover
Sheet, which is designed to provide the
minimum necessary information to
determine whether a fee is required for
review of an application, to determine
the amount of the fee required, and to
account for and track user fees.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Form FDA No.
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total
hours
3728 .....................................................................................
20
2
40
.08 (5 min.)
3.2
1 There
are no capital costs or operating and maintenance costs associated with this collection of information
Respondents to this collection of
information are generic animal drug
applicants. Based on FDA’s data base
system, there are an estimated 20
sponsors of new animal drugs
potentially subject to AGDUFA.
Dated: August 29, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–21177 Filed 9–1–16; 8:45 am]
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Countermeasures Injury
Compensation Program
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
In compliance with the
Paperwork Reduction Act of 1995,
HRSA has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
SUMMARY:
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review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period.
DATES: Comments on this ICR should be
received within 30 days of this notice.
ADDRESSES: Submit your comments,
including the ICR Title, to the desk
officer for HRSA, either by email to
OIRA_submission@omb.eop.gov or by
fax to 202–395–5806.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email the
HRSA Information Collection Clearance
Officer at paperwork@hrsa.gov or call
(301) 443–1984.
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60709
Federal Register / Vol. 81, No. 171 / Friday, September 2, 2016 / Notices
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Countermeasures Injury Compensation
Program OMB No. 0915–0334—
Extension.
Abstract: This is a request for an
extension of OMB approval of the
information collection requirements for
the Countermeasures Injury
Compensation Program (CICP). The
CICP, within the Health Resources and
Services Administration (HRSA),
administers the compensation program
specified by the Public Readiness and
Emergency Preparedness Act of 2005
(PREP Act). The 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 (all of these
parties may be ‘‘requesters’’). A
declaration is issued by the Secretary of
the Department of Health and Human
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 CICP benefits
(compensation) for the injury, the CICP
must review the Request for Benefits
Package, which includes the Request for
Benefits Form and Authorization for
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 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. 42 CFR 110.82(c).
Approval is requested for the required
continued information collection via the
Request for Benefits Package and for the
continued use of CICP’s mechanisms for
obtaining medical documentation and
supporting documentation collection.
During the eligibility review, the CICP
provides requesters with the
opportunity to supplement their
Request for Benefits with additional
medical records and supporting
documentation before a final
determination is made. The 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.
Approval is requested for the
continued use of the benefits
documentation package that the 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 the
CICP’s implementing regulation to
enable the CICP to determine the types
and amounts of benefits the requester
may be eligible to receive.
Need and Proposed Use of the
Information: The information collected
from requesters provides data and
documentation that is needed for the
CICP to determine: (1) The requester’s
eligibility to receive benefits; and (2) if
applicable, the type and amount of
benefits that may be awarded.
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
Form name
Number of
responses
per
respondent
Total
responses
Average
burden per
response
(in hours)
Total
burden
hours
100
100
30
30
1
1
1
1
100
100
30
30
11
2
.75
.125
1100
200
22.5
3.75
Total ..................................................................................................
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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
....................
100
....................
1326.25
* 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.
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60710
Federal Register / Vol. 81, No. 171 / Friday, September 2, 2016 / Notices
Jason E. Bennett,
Director, Division of the Executive Secretariat.
[FR Doc. 2016–21168 Filed 9–1–16; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Prospective Grant of Exclusive Patent
License: Development of Integrin αvβ3
Antagonists for Use in Imaging and
Therapy
National Institutes of Health,
HHS.
ACTION:
Notice.
This is notice, in accordance
with 35 U.S.C. 209(c)(1) and 37 CFR
part 404.7(a)(1)(i), that the National
Cancer Institute (NCI) and the Clinical
Center (CC), National Institutes of
Health, Department of Health and
Human Services, are contemplating the
grant of an exclusive license to
Advanced Imaging Projects, LLC, a
company having a place of business in
Boca Raton, FL, to practice the
inventions embodied in the following
patent applications:
mstockstill on DSK3G9T082PROD with NOTICES
SUMMARY:
Intellectual Property
U.S. Patent No. 7,300,940, filed 4
August 2004, titled ‘‘Integrin a-v b-3
antagonists for use in imaging and
therapy’’ (HHS Ref. No.: E–170–2004/0–
US–01);
PCT Application No. PCT/US2005/
027868, filed 3 August 2005, now
abandoned, titled ‘‘Integrin a-v b-3
antagonists for use in imaging and
therapy’’ (HHS Ref. No.: E–170–2004/0–
PCT–02);
Switzerland Patent No. 1781622,
titled ‘‘Integrin a-v b-3 antagonists for
use in imaging and therapy’’ filed 4
March 2007, issued 18 May 2011 (HHS
Ref. No.: E–170–2004/0–CH–04);
Germany Patent No. 602005028137.1,
titled ‘‘Integrin a-v b-3 antagonists for
use in imaging and therapy’’ filed 4
March 2007, issued 18 May 2011 (HHS
Ref. No.: E–170–2004/0–DE–05);
France Patent No. 1781622, titled
‘‘Integrin a-v b-3 antagonists for use in
imaging and therapy’’ filed 4 March
2007, issued 18 May 2011 (HHS Ref.
No.: E–170–2004/0–FR–060); and
Ireland Patent No. 1781622, titled
‘‘Integrin a-v b-3 antagonists for use in
imaging and therapy’’ filed 4 March
2007, issued 18 May 2011 (HHS Ref.
No.: E–170–2004/0–IE–07).
The patent rights in these inventions
have been assigned to the Government
of the United States of America. The
territory of the prospective exclusive
VerDate Sep<11>2014
18:25 Sep 01, 2016
Dated: August 29, 2016.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
Only written comments and/or
applications for a license which are
received by the NCI Technology
Transfer Center on or before September
19, 2016 will be considered.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DATES:
National Institutes of Health
AGENCY:
license may be worldwide, and the field
of use may be limited to ‘‘Conjugate of
Alpha-V beta-3 antagonist NIH–CC–013
for theranostic application to diagnose,
prevent and treat oncological,
infectious, ocular and cardiovascular
disorders.’’
Jkt 238001
Requests for copies of the
patent application(s), inquiries,
comments, and other materials relating
to the contemplated exclusive license
should be directed to: Jaime M. Greene,
M.S., Senior Licensing and Patenting
Manager, Technology Transfer Center,
National Cancer Institute, 9609 Medical
Center Drive, Rockville, MD 20850;
telephone: 240–276–6633; email:
greenejaime@mail.nih.gov.
ADDRESSES:
This
technology concerns small molecule
compositions that are antagonists for the
receptor integrin avb3. Integrins are
functional molecules for cell adhesion
activity that are expressed by the
majority of normal and cancer cells.
They are trans-membrane heterodimer
receptors that include two subunits, a
and b chains, that primarily allow cell
adhesion to extracellular matrix
components such as fibrillar collagen,
vitronectin and osteopontin. This
technology may be useful for the
development of diagnostics and
therapeutics for cancers and other
conditions involving the integrin avb3.
The prospective exclusive license will
be royalty bearing and will comply with
the terms and conditions of 35 U.S.C.
209 and 37 CFR part 404.7. The
prospective exclusive license may be
granted unless within fifteen (15) days
from the date of this published notice,
the NIH receives written evidence and
argument that establishes that the grant
of the license would not be consistent
with the requirements of 35 U.S.C. 209
and 37 CFR part 404.7.
Complete applications for a license in
the prospective field of use that are filed
in response to this notice will be treated
as objections to the grant of the
contemplated Exclusive Patent License
Agreement. Comments and objections
submitted to this notice will not be
made available for public inspection
and, to the extent permitted by law, will
not be released under the Freedom of
Information Act, 5 U.S.C. 552.
SUPPLEMENTARY INFORMATION:
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[FR Doc. 2016–21113 Filed 9–1–16; 8:45 am]
BILLING CODE 4140–01–P
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 209 and 37 CFR part 404 to
achieve expeditious commercialization
of results of federally-funded research
and development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
FOR FURTHER INFORMATION CONTACT:
Licensing information and copies of the
U.S. patent applications listed below
may be obtained by writing to the
indicated licensing contact at the
National Heart, Lung and Blood
Institute, Office of Technology Transfer
and Development, National Institutes of
Health, 31 Center Drive Room 4A29,
MSC2479, Bethesda, MD 20892–2479;
telephone: 301–402–5579. A signed
Confidential Disclosure Agreement may
be required to receive copies of the
patent applications.
SUPPLEMENTARY INFORMATION:
Technology descriptions follow.
SUMMARY:
Microscopy Systems for Instant
Internal Reflection Fluorescence/
Structured Illumination
Description of Technology: Structured
illumination microscopy (SIM) is a
method that uses sharply patterned light
and post-processing of images to
enhance image resolution (in its linear
form, doubling resolution). In
traditional SIM, a series of images are
acquired with a camera and
computationally processed to improve
resolution. This implementation of SIM
has also been combined with total
internal reflection fluorescence (TIRF),
but the implementation still requires
raw images relative to normal TIRF
microscopy, thereby slowing acquisition
9-fold relative to conventional,
diffraction-limited imaging. This TIRF/
E:\FR\FM\02SEN1.SGM
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]]>Agencies
[Federal Register Volume 81, Number 171 (Friday, September 2, 2016)]
[Notices]
[Pages 60708-60710]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21168]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Submission to OMB for
Review and Approval; Public Comment Request; Countermeasures Injury
Compensation Program
AGENCY: Health Resources and Services Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the Paperwork Reduction Act of 1995, HRSA
has submitted an Information Collection Request (ICR) to the Office of
Management and Budget (OMB) for review and approval. Comments submitted
during the first public review of this ICR will be provided to OMB. OMB
will accept further comments from the public during the review and
approval period.
DATES: Comments on this ICR should be received within 30 days of this
notice.
ADDRESSES: Submit your comments, including the ICR Title, to the desk
officer for HRSA, either by email to OIRA_submission@omb.eop.gov or by
fax to 202-395-5806.
FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance
requests submitted to OMB for review, email the HRSA Information
Collection Clearance Officer at paperwork@hrsa.gov or call (301) 443-
1984.
[[Page 60709]]
SUPPLEMENTARY INFORMATION:
Information Collection Request Title: Countermeasures Injury
Compensation Program OMB No. 0915-0334--Extension.
Abstract: This is a request for an extension of OMB approval of the
information collection requirements for the Countermeasures Injury
Compensation Program (CICP). The CICP, within the Health Resources and
Services Administration (HRSA), administers the compensation program
specified by the Public Readiness and Emergency Preparedness Act of
2005 (PREP Act). The 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 (all of these parties may be
``requesters''). A declaration is issued by the Secretary of the
Department of Health and Human 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 CICP benefits
(compensation) for the injury, the CICP must review the Request for
Benefits Package, which includes the Request for Benefits Form and
Authorization for 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 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. 42 CFR 110.82(c).
Approval is requested for the required continued information
collection via the Request for Benefits Package and for the continued
use of CICP's mechanisms for obtaining medical documentation and
supporting documentation collection. During the eligibility review, the
CICP provides requesters with the opportunity to supplement their
Request for Benefits with additional medical records and supporting
documentation before a final determination is made. The 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.
Approval is requested for the continued use of the benefits
documentation package that the 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 the CICP's implementing regulation to enable the CICP
to determine the types and amounts of benefits the requester may be
eligible to receive.
Need and Proposed Use of the Information: The information collected
from requesters provides data and documentation that is needed for the
CICP to determine: (1) The requester's eligibility to receive benefits;
and (2) if applicable, the type and amount of benefits that may be
awarded.
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
Number of responses Total burden per Total
Form name respondents per responses response burden
respondent (in hours) hours
----------------------------------------------------------------------------------------------------------------
Request for Benefits Form and Supporting 100 1 100 11 1100
Documentation.................................
Authorization for Use or Disclosure of Health 100 1 100 2 200
Information Form..............................
Additional Documentation and Certification..... 30 1 30 .75 22.5
Benefits Package and Supporting Documentation.. 30 1 30 .125 3.75
----------------------------------------------------------------
Total...................................... * 100 ........... 100 ........... 1326.25
----------------------------------------------------------------------------------------------------------------
* 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.
[[Page 60710]]
Jason E. Bennett,
Director, Division of the Executive Secretariat.
[FR Doc. 2016-21168 Filed 9-1-16; 8:45 am]
BILLING CODE 4165-15-P
