81 FR 60708 - Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Countermeasures Injury Compensation Program
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration Federal Register Volume 81, Issue 171 (September 2, 2016)
Health Resources and Services Administration
Federal Register Volume 81, Issue 171 (September 2, 2016)
| Page Range | 60708-60710 | |
| FR Document | 2016-21168 |
[Federal Register Volume 81, Number 171 (Friday, September 2, 2016)] [Notices] [Pages 60708-60710] From the Federal Register Online [www.thefederalregister.org] [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 [email protected] 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 [email protected] 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
![60708 Federal Register / Vol. 81, No. 171 / Friday, September 2, 2016 / Notices
claimed confidential information St., North Bethesda, MD 20852, the quality, utility, and clarity of the
redacted/blacked out, will be available PRAStaff@fda.hhs.gov. information to be collected; and (4)
for public viewing and posted on http:// SUPPLEMENTARY INFORMATION: Under the ways to minimize the burden of the
www.regulations.gov. Submit both PRA (44 U.S.C. 3501–3520), Federal collection of information on
copies to the Division of Dockets Agencies must obtain approval from the respondents, including through the use
Management. If you do not wish your Office of Management and Budget of automated collection techniques,
name and contact information to be (OMB) for each collection of when appropriate, and other forms of
made publicly available, you can information they conduct or sponsor. information technology.
provide this information on the cover ‘‘Collection of information’’ is defined Form FDA 3728, Animal Generic User
sheet and not in the body of your in 44 U.S.C. 3502(3) and 5 CFR Fee Act Cover Sheet—21 U.S.C. 379j–21
comments and you must identify this 1320.3(c) and includes Agency requests OMB Control Number 0910–0632—
information as ‘‘confidential.’’ Any or requirements that members of the Extension
information marked as ‘‘confidential’’ public submit reports, keep records, or
will not be disclosed except in provide information to a third party. Section 741 of the Federal Food, Drug,
accordance with 21 CFR 10.20 and other Section 3506(c)(2)(A) of the PRA (44 and Cosmetic Act (the FD&C Act) (21
applicable disclosure law. For more U.S.C. 3506(c)(2)(A)) requires Federal U.S.C. 379j–21) establishes three
information about FDA’s posting of Agencies to provide a 60-day notice in different kinds of user fees: (1) Fees for
comments to public dockets, see 80 FR the Federal Register concerning each certain types of abbreviated applications
56469, September 18, 2015, or access proposed collection of information, for generic new animal drugs; (2) annual
the information at: http://www.fda.gov/ including each proposed extension of an fees for certain generic new animal drug
regulatoryinformation/dockets/ existing collection of information,] products; and (3) annual fees for certain
default.htm. before submitting the collection to OMB sponsors of abbreviated applications for
for approval. To comply with this generic new animal drugs and/or
Docket: For access to the docket to
requirement, FDA is publishing notice investigational submissions for generic
read background documents or the
of the proposed collection of new animal drugs (21 U.S.C. 379j–
electronic and written/paper comments
information set forth in this document. 21(a)). Because concurrent submission
received, go to http://
With respect to the following of user fees with applications is
www.regulations.gov and insert the
collection of information, FDA invites required, the review of an application
docket number, found in brackets in the
comments on these topics: (1) Whether cannot begin until the fee is submitted.
heading of this document, into the
the proposed collection of information Form FDA 3728 is the AGDUFA Cover
‘‘Search’’ box and follow the prompts
is necessary for the proper performance Sheet, which is designed to provide the
and/or go to the Division of Dockets
of FDA’s functions, including whether minimum necessary information to
Management, 5630 Fishers Lane, Rm.
the information will have practical determine whether a fee is required for
1061, Rockville, MD 20852.
utility; (2) the accuracy of FDA’s review of an application, to determine
FOR FURTHER INFORMATION CONTACT: FDA estimate of the burden of the proposed the amount of the fee required, and to
PRA Staff, Office of Operations, Food collection of information, including the account for and track user fees.
and Drug Administration, Three White validity of the methodology and FDA estimates the burden of this
Flint North, 10A63, 11601 Landsdown assumptions used; (3) ways to enhance collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual Total
Form FDA No. responses per burden per
respondents responses hours
respondent response
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 DEPARTMENT OF HEALTH AND review and approval. Comments
information are generic animal drug HUMAN SERVICES submitted during the first public review
applicants. Based on FDA’s data base of this ICR will be provided to OMB.
system, there are an estimated 20 Health Resources and Services OMB will accept further comments from
sponsors of new animal drugs Administration the public during the review and
potentially subject to AGDUFA. approval period.
Agency Information Collection
Dated: August 29, 2016. Activities: Submission to OMB for DATES: Comments on this ICR should be
Leslie Kux, Review and Approval; Public Comment received within 30 days of this notice.
Associate Commissioner for Policy. Request; Countermeasures Injury ADDRESSES: Submit your comments,
[FR Doc. 2016–21177 Filed 9–1–16; 8:45 am]
Compensation Program including the ICR Title, to the desk
officer for HRSA, either by email to
BILLING CODE 4164–01–P AGENCY: Health Resources and Services OIRA_submission@omb.eop.gov or by
mstockstill on DSK3G9T082PROD with NOTICES
Administration, HHS. fax to 202–395–5806.
ACTION: Notice.
FOR FURTHER INFORMATION CONTACT: To
SUMMARY: In compliance with the request a copy of the clearance requests
Paperwork Reduction Act of 1995, submitted to OMB for review, email the
HRSA has submitted an Information HRSA Information Collection Clearance
Collection Request (ICR) to the Office of Officer at paperwork@hrsa.gov or call
Management and Budget (OMB) for (301) 443–1984.
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![60710 Federal Register / Vol. 81, No. 171 / Friday, September 2, 2016 / Notices
Jason E. Bennett, license may be worldwide, and the field Dated: August 29, 2016.
Director, Division of the Executive Secretariat. of use may be limited to ‘‘Conjugate of Richard U. Rodriguez,
[FR Doc. 2016–21168 Filed 9–1–16; 8:45 am] Alpha-V beta-3 antagonist NIH–CC–013 Associate Director, Technology Transfer
BILLING CODE 4165–15–P for theranostic application to diagnose, Center, National Cancer Institute.
prevent and treat oncological, [FR Doc. 2016–21113 Filed 9–1–16; 8:45 am]
infectious, ocular and cardiovascular BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND disorders.’’
HUMAN SERVICES
DATES: Only written comments and/or DEPARTMENT OF HEALTH AND
National Institutes of Health applications for a license which are HUMAN SERVICES
received by the NCI Technology
Prospective Grant of Exclusive Patent National Institutes of Health
Transfer Center on or before September
License: Development of Integrin αvβ3
19, 2016 will be considered.
Antagonists for Use in Imaging and Government-Owned Inventions;
Therapy ADDRESSES: Requests for copies of the Availability for Licensing
AGENCY: National Institutes of Health, patent application(s), inquiries,
AGENCY: National Institutes of Health,
HHS. comments, and other materials relating
HHS.
to the contemplated exclusive license
ACTION: Notice. ACTION: Notice.
should be directed to: Jaime M. Greene,
SUMMARY: This is notice, in accordance M.S., Senior Licensing and Patenting SUMMARY: The inventions listed below
with 35 U.S.C. 209(c)(1) and 37 CFR Manager, Technology Transfer Center, are owned by an agency of the U.S.
part 404.7(a)(1)(i), that the National National Cancer Institute, 9609 Medical Government and are available for
Cancer Institute (NCI) and the Clinical Center Drive, Rockville, MD 20850; licensing in the U.S. in accordance with
Center (CC), National Institutes of telephone: 240–276–6633; email: 35 U.S.C. 209 and 37 CFR part 404 to
Health, Department of Health and greenejaime@mail.nih.gov. achieve expeditious commercialization
Human Services, are contemplating the of results of federally-funded research
grant of an exclusive license to SUPPLEMENTARY INFORMATION: This
and development. Foreign patent
Advanced Imaging Projects, LLC, a technology concerns small molecule applications are filed on selected
company having a place of business in compositions that are antagonists for the inventions to extend market coverage
Boca Raton, FL, to practice the receptor integrin avb3. Integrins are for companies and may also be available
inventions embodied in the following functional molecules for cell adhesion for licensing.
patent applications: activity that are expressed by the FOR FURTHER INFORMATION CONTACT:
majority of normal and cancer cells. Licensing information and copies of the
Intellectual Property
They are trans-membrane heterodimer U.S. patent applications listed below
U.S. Patent No. 7,300,940, filed 4 receptors that include two subunits, a may be obtained by writing to the
August 2004, titled ‘‘Integrin a-v b-3 and b chains, that primarily allow cell indicated licensing contact at the
antagonists for use in imaging and adhesion to extracellular matrix National Heart, Lung and Blood
therapy’’ (HHS Ref. No.: E–170–2004/0– components such as fibrillar collagen, Institute, Office of Technology Transfer
US–01); vitronectin and osteopontin. This
PCT Application No. PCT/US2005/ and Development, National Institutes of
technology may be useful for the Health, 31 Center Drive Room 4A29,
027868, filed 3 August 2005, now
development of diagnostics and MSC2479, Bethesda, MD 20892–2479;
abandoned, titled ‘‘Integrin a-v b-3
antagonists for use in imaging and therapeutics for cancers and other telephone: 301–402–5579. A signed
therapy’’ (HHS Ref. No.: E–170–2004/0– conditions involving the integrin avb3. Confidential Disclosure Agreement may
PCT–02); The prospective exclusive license will be required to receive copies of the
Switzerland Patent No. 1781622, be royalty bearing and will comply with patent applications.
titled ‘‘Integrin a-v b-3 antagonists for the terms and conditions of 35 U.S.C. SUPPLEMENTARY INFORMATION:
use in imaging and therapy’’ filed 4 209 and 37 CFR part 404.7. The Technology descriptions follow.
March 2007, issued 18 May 2011 (HHS prospective exclusive license may be Microscopy Systems for Instant
Ref. No.: E–170–2004/0–CH–04); granted unless within fifteen (15) days Internal Reflection Fluorescence/
Germany Patent No. 602005028137.1, from the date of this published notice, Structured Illumination
titled ‘‘Integrin a-v b-3 antagonists for the NIH receives written evidence and
use in imaging and therapy’’ filed 4 Description of Technology: Structured
argument that establishes that the grant illumination microscopy (SIM) is a
March 2007, issued 18 May 2011 (HHS
of the license would not be consistent method that uses sharply patterned light
Ref. No.: E–170–2004/0–DE–05);
France Patent No. 1781622, titled with the requirements of 35 U.S.C. 209 and post-processing of images to
‘‘Integrin a-v b-3 antagonists for use in and 37 CFR part 404.7. enhance image resolution (in its linear
imaging and therapy’’ filed 4 March Complete applications for a license in form, doubling resolution). In
2007, issued 18 May 2011 (HHS Ref. the prospective field of use that are filed traditional SIM, a series of images are
No.: E–170–2004/0–FR–060); and in response to this notice will be treated acquired with a camera and
Ireland Patent No. 1781622, titled as objections to the grant of the computationally processed to improve
‘‘Integrin a-v b-3 antagonists for use in resolution. This implementation of SIM
mstockstill on DSK3G9T082PROD with NOTICES
contemplated Exclusive Patent License
imaging and therapy’’ filed 4 March Agreement. Comments and objections has also been combined with total
2007, issued 18 May 2011 (HHS Ref. submitted to this notice will not be internal reflection fluorescence (TIRF),
No.: E–170–2004/0–IE–07). made available for public inspection but the implementation still requires
The patent rights in these inventions and, to the extent permitted by law, will raw images relative to normal TIRF
have been assigned to the Government microscopy, thereby slowing acquisition
not be released under the Freedom of
of the United States of America. The 9-fold relative to conventional,
Information Act, 5 U.S.C. 552.
territory of the prospective exclusive diffraction-limited imaging. This TIRF/
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Document Created: 2018-02-09 11:55:51
Document Modified: 2018-02-09 11:55:51
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Comments on this ICR should be received within 30 days of this notice. | |
| Contact | To request a copy of the clearance requests submitted to OMB for review, email the HRSA Information Collection Clearance Officer at [email protected] or call (301) 443- 1984. | |
| FR Citation | 81 FR 60708 |
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