Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request, 12693-12695 [2014-04931]
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12693
Federal Register / Vol. 79, No. 44 / Thursday, March 6, 2014 / Notices
Darius Taylor,
Deputy, Information Collection Clearance
Officer.
[FR Doc. 2014–04939 Filed 3–5–14; 8:45 am]
BILLING CODE 4150–05–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: HHS–OS–21524–60D]
Agency Information Collection
Activities; Proposed Collection; Public
Comment Request
Office of the Secretary for
Health, HHS.
ACTION: Notice.
AGENCY:
In compliance with section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the Office of the
Secretary, Department of Health and
Human Services (HHS), announces
plans to submit an Information
Collection Request (ICR), described
below, to the Office of Management and
Budget (OMB). The ICR is for extending
the use of the approved information
collection assigned OMB control
number 0990–0278, which expires on
June 30, 2014. Prior to submitting that
SUMMARY:
ICR to OMB, OS seeks comments from
the public regarding the burden
estimate, below, or any other aspect of
the ICR.
DATES: Comments on the ICR must be
received on or before May 5, 2014.
ADDRESSES: Submit your comments to
Information.CollectionClearance@
hhs.gov or by calling (202) 690–6162.
FOR FURTHER INFORMATION CONTACT:
Information Collection Clearance staff,
Information.CollectionClearance@
hhs.gov or (202) 690–6162.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
document identifier HHS–OS–21524–
60D for reference.
Information Collection Request Title:
Federalwide Assurance Form—
Extension OMB No. 0990–0278,
Assistant Secretary for Health, Office for
Human Research Protections.
OMB No.: 0990–0278
Abstract: The Office for Human
Research Protections is requesting a
three year extension of the Federalwide
Assurance (FWA). The FWA is designed
to provide a simplified procedure for
institutions engaged in HHS-conducted
or supported research to satisfy the
assurance requirements of Section
491(a) of the Public Health Service Act
and HHS Regulations for the protection
of human subjects at 45 CFR 46.103.
The respondents are institutions
engaged in human subjects research that
is conducted or supported by HHS.
Need and Proposed Use of the
Information: The information collected
by OHRP through the FWA is the
minimum necessary to satisfy the
assurance requirements of the Public
Health Service Act and the requirements
of HHS regulations at 45 CFR 46.103.
Likely Respondents: Research
institutions engaged in HHS-conducted
or -supported research involving human
subjects.
Burden Statement: The estimate of the
hours per response assumes that
virtually all respondents will complete
the FWA form via the internet on an
interactive page on the OHRP Web site.
The time estimate includes an estimate
of the time needed to (i) read and
understand the instructions for
completing the FWA; (ii) read and
understand the FWA terms of assurance;
and (iii) enter the information requested
on the FWA form. The total annual
burden hours estimated for this ICR are
summarized in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
responses
per
respondent
Number of
respondents
Form name
Average
burden
per response
(in hours)
Total
burden hours
Federalwide Assurance (FWA) ........................................................................
11,050
2
30/60
11,050
Total ..........................................................................................................
........................
........................
........................
11,050
OS 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.
tkelley on DSK3SPTVN1PROD with NOTICES6
Darius Taylor,
Deputy, Information Collection Clearance
Officer.
[FR Doc. 2014–04933 Filed 3–5–14; 8:45 am]
BILLING CODE 4150–28–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
[Document Identifier: HHS–OS–20762–30D]
Agency Information Collection
Activities; Submission to OMB for
Review and Approval; Public Comment
Request
Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
In compliance with section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Office of the
Assistant Secretary for Financial
Resources, Office of Grants and
Acquisition Policy and Accountability,
Division of Acquisition, Department of
Health and Human Services, has
submitted an Information Collection
Request (ICR), described below, to the
SUMMARY:
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Fmt 4703
Sfmt 4703
Office of Management and Budget
(OMB) for review and approval. The ICR
is for a new collection. There were no
comments received during the first
public review of this ICR. OMB will
accept further comments from the
public on this ICR during the review
and approval period.
DATES: Comments on the ICR must be
received on or before April 7, 2014.
ADDRESSES: Submit your comments to
OIRA_submission@omb.eop.gov or via
facsimile to (202) 395–5806.
FOR FURTHER INFORMATION CONTACT:
Information Collection Clearance staff,
Information.CollectionClearance@
hhs.gov or (202) 690–6162.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
Information Collection Request Title
and document identifier HHS–OS–
20762–30D for reference.
E:\FR\FM\06MRN1.SGM
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12694
Federal Register / Vol. 79, No. 44 / Thursday, March 6, 2014 / Notices
tkelley on DSK3SPTVN1PROD with NOTICES6
Information Collection Request Title:
HHSAR 352.227–11 Patent Rights—
Exceptional Circumstances and
352.227–14 Rights in Data—Exceptional
Circumstances
Abstract: HHS found that
systematically, over a period of several
years, when Determinations of
Exceptional Circumstances (DECs) were
executed, additional legal protection for
the patent and data rights of third
parties beyond those covered by FAR
were necessary. A decision was made to
add two clauses—352.227–11 Patent
Rights—Exceptional Circumstances and
352.227–14 Rights in Data—Exceptional
Circumstances—to the HHS supplement
to the FAR, the HHS Acquisition
Regulation (HHSAR), to provide the
additional legal protection required.
These clauses would ensure that
providers of proprietary material(s) to
the government will retain all their
preexisting rights to their material(s),
and rights to any inventions made under
a contract or subcontract (at all tiers),
when a DEC has been executed. Rights
in data regulations concern the rights of
the Government, and organizations with
which the Government contracts, to
information developed under such
contracts. The delineation of such rights
is necessary in order to protect the
contractor’s rights to not disclose
proprietary data and to insure that nonproprietary data developed with public
funds is available to the public. As these
HHSAR clauses would be used in lieu
of the related FAR clauses, the clauses
also address the patent and data rights
currently covered in FAR clauses
52.227–11 and 52.227–14 prescribed
under FAR part 27. It is the policy and
objective of the Government to: (1) Use
the patent system to promote the use of
inventions arising from federally
supported research or development; (2)
Encourage maximum participation of
industry in federally supported research
and development efforts; (3) Ensure that
these inventions are used in a manner
to promote free competition and
enterprise without unduly encumbering
future research and discovery; (4)
Promote the commercialization and
public availability of the inventions
made in the United States by United
States industry and labor; (5) Ensure
that the Government obtains sufficient
rights in federally supported inventions
to meet the needs of the Government
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17:07 Mar 05, 2014
Jkt 232001
and protect the public against nonuse or
unreasonable use of inventions; and (6)
Minimize the costs of administering
patent policies.
Need and Proposed Use of the
Information: In order to accomplish the
objectives described above through the
clauses, it will be necessary to collect
the information described below. All
submissions are considered critical to
the Government ensuring the patent and
data rights of the Contractor,
Government and third parties are
protected appropriately.
Likely Respondents: It is anticipated
that the respondents to the collection of
information will be the prime
contractor(s), subcontractor(s) and third
party providers for contracts awarded
that include the two clauses 352.227–11
Patent Rights—Exceptional
Circumstances and 352.227–14 Rights in
Data—Exceptional Circumstances.
Identify type of respondents: It is
anticipated that technical, legal,
management and administrative
personnel from the prime contractor(s),
subcontractor(s) and providers of third
party materials for contracts awarded
that include the two clauses 352.227–11
Patent Rights—Exceptional
Circumstances and 352.227–14 Rights in
Data—Exceptional Circumstances will
provide the responses to the information
collection required.
Burden Statement: Clause 352.227–11
contains the following information
collections.
(a) A request for a determination of
whether the Contractor or the employer
inventor is entitled to retain such
greater rights must be submitted to the
Agency Contracting Officer;
(b) The Contractor shall disclose in
writing each Subject Invention to the
Agency Contracting Office and to the
Director, Division of Extramural
Inventions and Technology Resources
(DEITR);
(c) The Contractor agrees to execute or
to have executed and promptly deliver
to the Agency all instruments necessary
to: 1. Establish or confirm the rights the
Government has throughout the world
in Subject Inventions . . . and 2. convey
title to a Third party assignee . . . and
enable the Third party assignee to
obtain patent protection throughout the
world in that Subject Invention;
(d) The Contractor agrees to require,
by written agreement, its employees,
PO 00000
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Fmt 4703
Sfmt 4703
other than clerical and nontechnical
employees, to disclose promptly in
writing to personnel identified as
responsible for the administration of
patent matters and in a format suggested
by the Contractor, each Subject
Invention made under contract;
(e) The Contractor agrees to provide a
final invention statement and
certification prior to the close-out of the
contract listing all Subject Inventions or
stating that there were none;
(f) The Contractor agrees to submit, on
request, periodic reports no more
frequently than annually on the
utilization of a Subject Invention or on
efforts at obtaining such utilization that
are being made by the Contractor or its
licensees or assignees when a request
under subparagraph b.3. has been
granted by the Agency; and
(g) All invention disclosures and
requests for greater rights shall be sent
to the Agency Contracting officer.
Additionally, a copy of all disclosures,
confirmatory licenses to the
Government, face page of the patent
applications, waivers and other routine
communications under this funding
agreement at all tiers must be sent to
. . . https://www.iEdison.gov. Clause
352.227–14 contains the following two
collections of information.
(h) ‘‘Accordingly, the Contractor will
provide the Contracting Officer a copy
of any proposed publication or other
public disclosure relating to the
proposed publication or other public
disclosure relating to the work
performed under this contract at least 30
days in advance of the disclosure.’’ This
information collection is being done to
insure that the Contractor does not
prematurely publish information
concerning possible inventions made
under this contract so that the ability to
obtain patent protection on such
inventions is adversely affected.
(i) ‘‘The Contracting Officer will make
written inquiry to the Contractor
affording the Contractor 60 days from
receipt of the inquiry to provide written
justification to substantiate the
propriety of the markings.’’ This
information collection is being done to
preserve the Government’s right to
cancel or ignore the markings at any
time after the stated period, making the
data no longer subject to any disclosure
prohibitions.
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12695
Federal Register / Vol. 79, No. 44 / Thursday, March 6, 2014 / Notices
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Information collection (see above list ‘‘Burden
statement’’ for legend)
Number of
Respondents
Number of
responses per
respondent
Average
burden per
response
(hours)
Total burden
hours
(a) .....................................................................................................................
(b) .....................................................................................................................
(c) .....................................................................................................................
(d) .....................................................................................................................
(e) .....................................................................................................................
(f) ......................................................................................................................
(g) .....................................................................................................................
(h) .....................................................................................................................
(i) ......................................................................................................................
63
63
63
63
63
63
63
63
63
1
1
3
3
1
1
3
3
3
8
12
12
14
10
8
8
3
8
504
756
2268
2646
630
504
1512
567
1512
Total ..........................................................................................................
63
19
83
10,899
Darius Taylor,
Deputy, Information Collection Clearance
Officer.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2014–04931 Filed 3–5–14; 8:45 am]
Food and Drug Administration
BILLING CODE 4150–24–P
[Docket No. FDA–2014–N–0237]
Report to Congress; Report on the
Food and Drug Administration’s Policy
To Be Proposed Regarding Premarket
Notification Requirements for
Modifications to Legally Marketed
Devices; Notice to Public of Web Site
Location of Report to Congress
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
tkelley on DSK3SPTVN1PROD with NOTICES6
Clinical Laboratory Improvement
Advisory Committee, Centers for
Disease Control and Prevention:
Notice of Charter Renewal
AGENCY:
ACTION:
This gives notice under the Federal
Advisory Committee Act (Public Law
92–463) of October 6, 1972, that the
Clinical Laboratory Improvement
Advisory Committee, Centers for
Disease Control and Prevention (CDC),
Department of Health and Human
Services (HHS), has been renewed for a
2-year period through February 19,
2016.
For information, contact Devery
Howerton, Ph.D., Designated Federal
Officer, Clinical Laboratory
Improvement Advisory Committee,
1600 Clifton Road NE., Mailstop E–56,
Atlanta, Georgia 30333, telephone 404–
498–2602 or via email at dxh7@cdc.gov.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2014–04935 Filed 3–5–14; 8:45 am]
BILLING CODE 4163–18–P
VerDate Mar<15>2010
17:07 Mar 05, 2014
Jkt 232001
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA or the Agency) is
announcing the Web site location where
the Agency has posted the report
entitled ‘‘Report to Congress; Report on
FDA’s Policy to be Proposed Regarding
Premarket Notification Requirements for
Modifications to Legally Marketed
Devices.’’ In addition, FDA has
established a docket where stakeholders
may provide comments.
DATES: Submit either electronic or
written comments by June 4, 2014.
ADDRESSES: Submit electronic
comments on this document to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Mike Ryan, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1615, Silver Spring,
MD 20993–0002, 301–796–6283.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
The Food and Drug Administration
Safety and Innovation Act (FDASIA)
(Pub. L. 112–144) became law on July 9,
PO 00000
Frm 00010
Fmt 4703
Sfmt 4703
2012. FDASIA added section 510(n)(2)
to the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C.
360(n)(2)). This new provision requires,
no later than 18 months after enactment
of FDASIA, the Secretary of Health and
Human Services to submit to the
Committee on Energy and Commerce of
the House of Representatives and the
Committee on Health, Education, Labor,
and Pensions of the Senate a report on
when a premarket notification under
section 510(k) of the FD&C Act (or a
‘‘510(k)’’) should be submitted for a
modification to a legally marketed
510(k) device. This report fulfills that
requirement.
This notice announces the Web site
location of ‘‘Report to Congress; Report
on FDA’s Policy to be Proposed
Regarding Premarket Notification
Requirements for Modifications to
Legally Marketed Devices.’’ FDA invites
interested persons to submit comments
on this report. FDA has established a
docket where comments may be
submitted (see ADDRESSES). FDA
believes this docket is an important tool
for receiving information from
interested parties and for sharing this
information with the public. To access
‘‘Report to Congress; Report on FDA’s
Policy to be Proposed Regarding
Premarket Notification Requirements for
Modifications to Legally Marketed
Devices,’’ visit FDA’s Web site https://
www.fda.gov/AboutFDA/CentersOffices/
OfficeofMedicalProductsandTobacco/
CDRH/CDRHReports/ucm269873.htm.
II. Request for Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
E:\FR\FM\06MRN1.SGM
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]]>Agencies
[Federal Register Volume 79, Number 44 (Thursday, March 6, 2014)]
[Notices]
[Pages 12693-12695]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-04931]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
[Document Identifier: HHS-OS-20762-30D]
Agency Information Collection Activities; Submission to OMB for
Review and Approval; Public Comment Request
AGENCY: Department of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Office of the Assistant Secretary for
Financial Resources, Office of Grants and Acquisition Policy and
Accountability, Division of Acquisition, Department of Health and Human
Services, has submitted an Information Collection Request (ICR),
described below, to the Office of Management and Budget (OMB) for
review and approval. The ICR is for a new collection. There were no
comments received during the first public review of this ICR. OMB will
accept further comments from the public on this ICR during the review
and approval period.
DATES: Comments on the ICR must be received on or before April 7, 2014.
ADDRESSES: Submit your comments to OIRA_submission@omb.eop.gov or via
facsimile to (202) 395-5806.
FOR FURTHER INFORMATION CONTACT: Information Collection Clearance
staff, Information.CollectionClearance@hhs.gov or (202) 690-6162.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the Information Collection Request Title
and document identifier HHS-OS-20762-30D for reference.
[[Page 12694]]
Information Collection Request Title: HHSAR 352.227-11 Patent
Rights--Exceptional Circumstances and 352.227-14 Rights in Data--
Exceptional Circumstances
Abstract: HHS found that systematically, over a period of several
years, when Determinations of Exceptional Circumstances (DECs) were
executed, additional legal protection for the patent and data rights of
third parties beyond those covered by FAR were necessary. A decision
was made to add two clauses--352.227-11 Patent Rights--Exceptional
Circumstances and 352.227-14 Rights in Data--Exceptional
Circumstances--to the HHS supplement to the FAR, the HHS Acquisition
Regulation (HHSAR), to provide the additional legal protection
required. These clauses would ensure that providers of proprietary
material(s) to the government will retain all their preexisting rights
to their material(s), and rights to any inventions made under a
contract or subcontract (at all tiers), when a DEC has been executed.
Rights in data regulations concern the rights of the Government, and
organizations with which the Government contracts, to information
developed under such contracts. The delineation of such rights is
necessary in order to protect the contractor's rights to not disclose
proprietary data and to insure that non-proprietary data developed with
public funds is available to the public. As these HHSAR clauses would
be used in lieu of the related FAR clauses, the clauses also address
the patent and data rights currently covered in FAR clauses 52.227-11
and 52.227-14 prescribed under FAR part 27. It is the policy and
objective of the Government to: (1) Use the patent system to promote
the use of inventions arising from federally supported research or
development; (2) Encourage maximum participation of industry in
federally supported research and development efforts; (3) Ensure that
these inventions are used in a manner to promote free competition and
enterprise without unduly encumbering future research and discovery;
(4) Promote the commercialization and public availability of the
inventions made in the United States by United States industry and
labor; (5) Ensure that the Government obtains sufficient rights in
federally supported inventions to meet the needs of the Government and
protect the public against nonuse or unreasonable use of inventions;
and (6) Minimize the costs of administering patent policies.
Need and Proposed Use of the Information: In order to accomplish
the objectives described above through the clauses, it will be
necessary to collect the information described below. All submissions
are considered critical to the Government ensuring the patent and data
rights of the Contractor, Government and third parties are protected
appropriately.
Likely Respondents: It is anticipated that the respondents to the
collection of information will be the prime contractor(s),
subcontractor(s) and third party providers for contracts awarded that
include the two clauses 352.227-11 Patent Rights--Exceptional
Circumstances and 352.227-14 Rights in Data--Exceptional Circumstances.
Identify type of respondents: It is anticipated that technical,
legal, management and administrative personnel from the prime
contractor(s), subcontractor(s) and providers of third party materials
for contracts awarded that include the two clauses 352.227-11 Patent
Rights--Exceptional Circumstances and 352.227-14 Rights in Data--
Exceptional Circumstances will provide the responses to the information
collection required.
Burden Statement: Clause 352.227-11 contains the following
information collections.
(a) A request for a determination of whether the Contractor or the
employer inventor is entitled to retain such greater rights must be
submitted to the Agency Contracting Officer;
(b) The Contractor shall disclose in writing each Subject Invention
to the Agency Contracting Office and to the Director, Division of
Extramural Inventions and Technology Resources (DEITR);
(c) The Contractor agrees to execute or to have executed and
promptly deliver to the Agency all instruments necessary to: 1.
Establish or confirm the rights the Government has throughout the world
in Subject Inventions . . . and 2. convey title to a Third party
assignee . . . and enable the Third party assignee to obtain patent
protection throughout the world in that Subject Invention;
(d) The Contractor agrees to require, by written agreement, its
employees, other than clerical and nontechnical employees, to disclose
promptly in writing to personnel identified as responsible for the
administration of patent matters and in a format suggested by the
Contractor, each Subject Invention made under contract;
(e) The Contractor agrees to provide a final invention statement
and certification prior to the close-out of the contract listing all
Subject Inventions or stating that there were none;
(f) The Contractor agrees to submit, on request, periodic reports
no more frequently than annually on the utilization of a Subject
Invention or on efforts at obtaining such utilization that are being
made by the Contractor or its licensees or assignees when a request
under subparagraph b.3. has been granted by the Agency; and
(g) All invention disclosures and requests for greater rights shall
be sent to the Agency Contracting officer. Additionally, a copy of all
disclosures, confirmatory licenses to the Government, face page of the
patent applications, waivers and other routine communications under
this funding agreement at all tiers must be sent to . . . https://www.iEdison.gov. Clause 352.227-14 contains the following two
collections of information.
(h) ``Accordingly, the Contractor will provide the Contracting
Officer a copy of any proposed publication or other public disclosure
relating to the proposed publication or other public disclosure
relating to the work performed under this contract at least 30 days in
advance of the disclosure.'' This information collection is being done
to insure that the Contractor does not prematurely publish information
concerning possible inventions made under this contract so that the
ability to obtain patent protection on such inventions is adversely
affected.
(i) ``The Contracting Officer will make written inquiry to the
Contractor affording the Contractor 60 days from receipt of the inquiry
to provide written justification to substantiate the propriety of the
markings.'' This information collection is being done to preserve the
Government's right to cancel or ignore the markings at any time after
the stated period, making the data no longer subject to any disclosure
prohibitions.
[[Page 12695]]
Total Estimated Annualized Burden--Hours
----------------------------------------------------------------------------------------------------------------
Average
Information collection (see above list ``Burden Number of Number of burden per Total burden
statement'' for legend) Respondents responses per response hours
respondent (hours)
----------------------------------------------------------------------------------------------------------------
(a)............................................. 63 1 8 504
(b)............................................. 63 1 12 756
(c)............................................. 63 3 12 2268
(d)............................................. 63 3 14 2646
(e)............................................. 63 1 10 630
(f)............................................. 63 1 8 504
(g)............................................. 63 3 8 1512
(h)............................................. 63 3 3 567
(i)............................................. 63 3 8 1512
---------------------------------------------------------------
Total....................................... 63 19 83 10,899
----------------------------------------------------------------------------------------------------------------
Darius Taylor,
Deputy, Information Collection Clearance Officer.
[FR Doc. 2014-04931 Filed 3-5-14; 8:45 am]
BILLING CODE 4150-24-P
