Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request, 26975-26976 [2014-10875]
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Federal Register / Vol. 79, No. 91 / Monday, May 12, 2014 / Notices
matured to the point that their
introduction into the clinic appears
practical and useful. Fundamental to
using IVDs in the clinic is the need to
demonstrate that the tests are safe and
effective—that the results claimed are
accurate and precise and that the
interpretation of the results are
supported by science. FDA’s regulatory
process is designed to ensure that
intended use claims are supported with
appropriate data. However, the range of
variables that can be included in
proteomic IVDs such as technological
approaches, variety of sample types and
preparation methods, data capture, and
analysis algorithms, poses unique
regulatory challenges, as more complex
the information gathered, more
challenging is the validation of results.
At this point, what we need is a
regulatory framework, tuned to
proteomic technologies, which will
facilitate the introduction of validated
IVDs into the clinic.
The intent of this workshop is not to
discuss the limitations and strengths of
the proteomic discovery process. The
theoretical analytical performance of
proteomic technologies have been well
demonstrated, and in the past few years
a number of initiatives have been
launched to bring standardization and
quality control to the discovery and preclinical development of proteomicbased assays. However, this level of
quality control does not ensure that
these assays have been validated for
their intended use as IVDs tests that are
used for diagnosis of disease and
clinical management of patients; e.g.,
assessment of risk, monitoring of
disease, prediction of response to
therapy, and selection of treatment.
Strategies are needed that will guide
the successful transfer of research and
discovery-level assays into the clinic.
This includes their use in clinical trials,
so that the analytical and clinical
validity of the test procedure and
outcome are assured. As a general rule,
the requirements for analytical and
clinical validation of IVDs are much
greater than the studies that are
commonly performed in a research and
development setting. To support the
least burdensome approach to assay
development, FDA is willing to discuss
unconventional approaches to IVD
validation driven by, for example, the
theoretical precision of multiple
reaction monitoring assays. However,
theoretical performance must be
balanced by the recognition that there
are few, if any, recognized reference
standards for the analytes or the assays
with which to assess the performance of
proteomic IVDs. The impact of the lack
of standards may be substantial: Assays
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that combine the measurements of
several, if not dozens, of individual
analytes into a single, actionable
‘‘score’’ may require validation of each
individual analyte separately and in
combination. Thus, the objective of this
public workshop is to obtain feedback
from academia, government, industry,
clinical laboratories, and other
stakeholders on the development of a
regulatory approach that may reduce the
burden of assay validation while
assuring that the assays are safe and
effective.
II. Topics for Discussion at the Public
Workshop
We plan to include the following
topics at the public workshop.
• State of the art: Current state of
proteomic IVD landscape and FDA’s
perspectives;
• Community initiatives: Overview of
community (governmental and nongovernmental) initiatives to help
standardize proteomic technologies and
provide quality control to discovery;
• Success stories: Description of FDA
experience in the clearance of IVDs that
use proteomic technologies, with
lessons learned and challenges
discovered in bringing proteomic-based
assays to the clinic; and
• Case study open discussion: In an
open discussion, FDA will present a
hypothetical case study that includes
assay design and validation issues with
which FDA has experience. The goal is
to stimulate discussion with attendees
regarding what expectations from FDA
are reasonable, what validation by
manufacturers is possible and other
challenges inherent in bringing these
tests to the clinic and the Agency.
Possible points of discussion will be
solicited from the attendees, and may
include:
Æ How can or should the FDA use
community-developed reference
standards/assays to assess IVD validity?
Æ How can manufacturers assess
accuracy in a multiplex/multipeak assay
without a reference standard for the
analytes?
Æ Are there general rules for assay
validation that cannot or should not be
applied to different platforms?
Æ How can or should late-stage
validation considerations be
incorporated into early-stage assay
development?
Dated: May 7, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–10787 Filed 5–9–14; 8:45 am]
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26975
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
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Health
Resources and Services Administration
(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 no later than June 11, 2014.
ADDRESSES: Submit your comments,
including the Information Collection
Request 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.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Rural Health Care Services Outreach
Supplement Performance Measures.
OMB No.: 0915–xxxx—NEW.
Abstract: The fiscal year (FY) 2013
Supplemental Funding to the Rural
Health Care Services Outreach Program
grantees is a one-time supplemental
funding under Section 330A(e) of the
Public Health Service (PHS) Act (42
U.S.C. 254c(e)) to promote rural health
care services outreach by expanding the
delivery of health care services to
include new and enhanced services in
rural areas. The supplemental funding
will specifically focus on supporting the
current scope of their project, allowing
grantees to further enhance outreach
and enrollment assistance activities in
their communities. This supplemental
funding will support the Affordable
Care Act’s outreach and enrollment
activities to the Health Insurance
Marketplaces. Grantees will be able to
raise awareness of affordable insurance
options and provide assistance and
SUMMARY:
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26976
Federal Register / Vol. 79, No. 91 / Monday, May 12, 2014 / Notices
information to the uninsured about
enrolling in available sources of
insurance, such as Medicare, Medicaid,
the Children’s Health Insurance
Program, and private insurance in the
Marketplace through this supplemental
funding.
The overarching goal is to increase the
number of eligible individuals educated
about their coverage options and
enrollees to the Health Insurance
Marketplaces or other available sources
of insurance, such as Medicare,
Medicaid, and the Children’s Health
Insurance Program as a result of this
supplemental funding.
Need and Proposed Use of the
Information: For this program,
performance measures were drafted to
provide data to the program and to
enable HRSA to provide aggregate
program data. These measures cover the
principal topic areas of interest to the
Office of Rural Health Policy, including:
(a) Organizational information; (b)
outreach and enrollment personnel; (c)
outreach and education; (d) enrollment;
and (e) additional resources. Several
measures will be used for this program.
A 60-day Federal Register notice was
published in the Federal Register on
February 18, 2014 (see, 79 Fed. Reg.
9235). There were no comments.
Likely Respondents: The respondents
would be recipients of the Rural Health
Care Services Outreach supplemental
funding award.
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
Rural Health Care Services Outreach Supplement Performance Measures ..........................................................
52
1
52
1.5
78
Total ..............................................................................
52
1
52
1.5
78
Dated: May 6, 2014.
Bahar Niakan,
Director, Division of Policy and Information
Coordination.
[FR Doc. 2014–10875 Filed 5–9–14; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects (Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995), the
Health Resources and Services
Administration (HRSA) announces
plans to submit an Information
Collection Request (ICR), described
below, to the Office of Management and
Budget (OMB). Prior to submitting the
ICR to OMB, HRSA seeks comments
from the public regarding the burden
estimate, below, or any other aspect of
the ICR.
emcdonald on DSK67QTVN1PROD with NOTICES
SUMMARY:
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Comments on this Information
Collection Request must be received no
later than July 11, 2014.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 10–29, Parklawn
Building, 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 paperwork@hrsa.gov
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:
Health Education Assistance Loan
(HEAL) Program: Lender’s Application
for Insurance Claim Form and Request
for Collection Assistance Form OMB
No. 0915–0036—Extension.
Abstract: The clearance request is for
an extension of two forms that are
currently approved by OMB. HEAL
lenders use the Lenders Application for
Insurance Claim to request payment
from the federal government for
federally insured loans lost due to
borrowers’ death, disability, bankruptcy,
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or default. The Request for Collection
Assistance form is submitted by HEAL
lenders to request federal assistance
with the collection of delinquent
payments from HEAL borrowers.
Need and Proposed Use of the
Information: Lender’s Application for
Insurance Claim Form—This form is
used to obtain information about the
claim and to determine if the lending
institution has complied with statutory
and regulatory requirements for
payment of the insurance claim.
Failure to submit the required
documentation or not filing the form
promptly may result in a claim being
penalized or denied. Request for
Collection Assistance Form—When a
borrower is 90 days delinquent, the
lender must immediately request preclaims assistance from the Public Health
Service. Pre-claims assistance consists
of three progressively stronger letters
urging the borrower to contact his or her
lender before litigation is initiated
against the borrower. The Secretary does
not pay a default claim if the lender fails
to request pre-claims assistance.
Likely Respondents: HEAL Lenders
and Servicers.
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
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[Federal Register Volume 79, Number 91 (Monday, May 12, 2014)]
[Notices]
[Pages 26975-26976]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-10875]
-----------------------------------------------------------------------
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
AGENCY: Health Resources and Services Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Health Resources and Services Administration
(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 no later than June 11,
2014.
ADDRESSES: Submit your comments, including the Information Collection
Request 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.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title: Rural Health Care Services
Outreach Supplement Performance Measures.
OMB No.: 0915-xxxx--NEW.
Abstract: The fiscal year (FY) 2013 Supplemental Funding to the
Rural Health Care Services Outreach Program grantees is a one-time
supplemental funding under Section 330A(e) of the Public Health Service
(PHS) Act (42 U.S.C. 254c(e)) to promote rural health care services
outreach by expanding the delivery of health care services to include
new and enhanced services in rural areas. The supplemental funding will
specifically focus on supporting the current scope of their project,
allowing grantees to further enhance outreach and enrollment assistance
activities in their communities. This supplemental funding will support
the Affordable Care Act's outreach and enrollment activities to the
Health Insurance Marketplaces. Grantees will be able to raise awareness
of affordable insurance options and provide assistance and
[[Page 26976]]
information to the uninsured about enrolling in available sources of
insurance, such as Medicare, Medicaid, the Children's Health Insurance
Program, and private insurance in the Marketplace through this
supplemental funding.
The overarching goal is to increase the number of eligible
individuals educated about their coverage options and enrollees to the
Health Insurance Marketplaces or other available sources of insurance,
such as Medicare, Medicaid, and the Children's Health Insurance Program
as a result of this supplemental funding.
Need and Proposed Use of the Information: For this program,
performance measures were drafted to provide data to the program and to
enable HRSA to provide aggregate program data. These measures cover the
principal topic areas of interest to the Office of Rural Health Policy,
including: (a) Organizational information; (b) outreach and enrollment
personnel; (c) outreach and education; (d) enrollment; and (e)
additional resources. Several measures will be used for this program. A
60-day Federal Register notice was published in the Federal Register on
February 18, 2014 (see, 79 Fed. Reg. 9235). There were no comments.
Likely Respondents: The respondents would be recipients of the
Rural Health Care Services Outreach supplemental funding award.
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
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total burden per Total burden
Form name respondents responses per responses response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
Rural Health Care Services 52 1 52 1.5 78
Outreach Supplement Performance
Measures.......................
-------------------------------------------------------------------------------
Total....................... 52 1 52 1.5 78
----------------------------------------------------------------------------------------------------------------
Dated: May 6, 2014.
Bahar Niakan,
Director, Division of Policy and Information Coordination.
[FR Doc. 2014-10875 Filed 5-9-14; 8:45 am]
BILLING CODE 4165-15-P
