Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request, 47655-47656 [2014-19219]
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Federal Register / Vol. 79, No. 157 / Thursday, August 14, 2014 / Notices
trial designs that may provide evidence
of efficacy to support drug approval.
The Agency encourages individuals,
patient advocates, industry, consumer
groups, health care professionals,
researchers, and other interested
persons to attend this public workshop.
Transcripts: Please be advised that as
soon as a transcript is available, it will
be accessible at https://
www.regulations.gov. It may be viewed
at the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. A transcript
will also be available in either hardcopy
or on CD–ROM, after submission of a
Freedom of Information request. Written
requests are to be sent to Division of
Freedom of Information (ELEM–1029),
Food and Drug Administration, 12420
Parklawn Dr., Element Bldg., Rockville,
MD 20857. Transcripts will also be
available on the Internet at https://
www.fda.gov/Drugs/NewsEvents/
ucm132703.htm approximately 45 days
after the workshop.
Dated: August 8, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–19257 Filed 8–13–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0334]
Postmarketing Safety Reports for
Human Drug and Biological Products;
Electronic Submission Requirements;
Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration (FDA) is correcting a
final rule entitled ‘‘Postmarketing Safety
Reports for Human Drug and Biological
Products; Electronic Submission
Requirements’’ that appeared in the
Federal Register of June 10, 2014 (79 FR
33072). The document amended FDA’s
postmarketing safety reporting
regulations for human drug and
biological products to require that
persons subject to mandatory reporting
requirements submit safety reports in an
electronic format that FDA can process,
review, and archive. The document was
published with incorrect information
regarding the availability of the
International Conference on
Harmonization’s (ICH) data elements for
tkelley on DSK3SPTVN1PROD with NOTICES
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postmarketing safety reports. The
document also published with an
incorrect statement regarding the impact
of the final rule on small entities. This
document corrects those errors.
FOR FURTHER INFORMATION CONTACT: Jean
Chung, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 4466, Silver Spring,
MD 20993–0002, 301–796–1874; or
Stephen Ripley, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7268,
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION: In the
Federal Register of June 10, 2014, in FR
Doc. 2014–13480, the following
corrections are made:
1. On page 33074, in the first column,
under ‘‘Introduction’’, footnote 6 is
corrected to read: ‘‘ICH data elements
for postmarketing safety reports are
provided in the guidance for industry
entitled ‘E2B Electronic Transmission of
Individual Case Safety Reports
Implementation Guide—Data Elements
and Message Specification,’ available at
https://www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm.’’
2. On page 33084, in the second
column, under ‘‘Analysis of Impacts’’,
the first full sentence is corrected to
read: ‘‘Because the average small entity
submits few safety reports and the
Agency’s Web-based system for
submitting reports electronically will
require little additional cost per report,
the Agency certifies that this final rule
will not have a significant economic
impact on a substantial number of small
entities.’’
Dated: August 8, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–19255 Filed 8–13–14; 8:45 am]
BILLING CODE 4164–01–P
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:
PO 00000
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47655
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 September 15,
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:
Federal Tort Claims Act (FTCA) Free
Clinic Application OMB No. 0915–
0293—Revision.
Abstract: Under 42 U.S.C. 233(o) and
Program Assistance Letter (PAL) 2014–
04, ‘‘Calendar Year 2015 Federal Tort
Claims Act (FTCA) Deeming
Application for Free Clinics,’’ free
clinics are required to submit annual
applications for deeming of qualified
health care professionals, board
members, officers, and contractors for
purposes of FTCA medical malpractice
coverage for negligent acts and
omissions that arise from the
performance of medical, surgical,
dental, or related functions within the
scope of the covered individual’s
deemed employment. HRSA proposes
modifying the application forms to
reflect changes to eligible personnel
made by section 10608 of the Affordable
Care Act, which extended FTCA
medical malpractice liability protection
to free clinic board members, officers,
employees, and contractors.
Additionally, HRSA proposes upgrading
the application to provide for electronic
submissions. Specifically, the
modifications include: (1) Inclusion of
board members, officers, employees,
and contractors into one comprehensive
application that also includes volunteer
health care professionals and (2) a fully
electronic application that can be
submitted via HRSA’s web-based
application system, the Electronic
Handbooks (EHBs). It is anticipated that
SUMMARY:
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47656
Federal Register / Vol. 79, No. 157 / Thursday, August 14, 2014 / Notices
these modifications will decrease the
time and effort required to complete the
current OMB approved FTCA
application forms.
Need and Proposed Use of the
Information: Deemed status for FTCA
medical malpractice coverage requires
HRSA approval of an application for
deeming of certain eligible individuals
from a sponsoring free clinic. The FTCA
Free Clinic deeming application is an
electronic application submitted to
HRSA through the EHBs as part of the
process of deeming qualified health care
professionals, board members, officers,
and individual contractors. Sponsoring
clinics are required to submit a
completed electronic application in
addition to other required documents as
required by section 224(o) of the Public
Health Service Act (42 U.S.C. 233(o)).
Applications are reviewed by program
staff before a deeming determination is
made.
Likely Respondents: Respondents
include nonprofit private entities that
meet the statutory and programmatic
requirements as stated in section 224(o)
of the Public Health Service Act (42
U.S.C. 233(o)) and implementing HRSA
policy guidance.
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
FTCA Free Clinics Program Application ..............................
227
1
227
2
681
Total ..............................................................................
227
1
227
2
681
Dated: August 8, 2014.
Jackie Painter,
Acting Director, Division of Policy and
Information Coordination.
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.
ADDRESSES:
[FR Doc. 2014–19219 Filed 8–13–14; 8:45 am]
BILLING CODE 4165–15–P
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.
FOR FURTHER INFORMATION CONTACT:
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.
DATES: Comments on this Information
Collection Request must be received no
later than October 14, 2014.
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When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
Be The Match® Patient Services Survey
OMB No. 0915–0212—Revision.
Abstract: National Marrow Donor
Program®/Be The Match® is dedicated
to helping patients and families get the
support and information they need to
learn about their disease and treatment
options, prepare for transplant, and
thrive after transplant. The information
and resources provided are intended to
help navigate the bone marrow or cord
blood transplant (transplant) process.
Participant feedback is essential to
understand the needs for transplant
support services and educational
information across a diverse population.
This information will be used to
determine helpfulness of existing
services and resources. Feedback is also
SUPPLEMENTARY INFORMATION:
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used to identify areas for improvement
and develop future programs.
Need and Proposed Use of the
Information: Barriers to access to bone
marrow or cord blood transplant
(transplant) related care and educational
information are multi-factorial.
Feedback from participants is essential
to better understand the changing needs
for services and information as well as
to demonstrate the effectiveness of
existing services. The primary use for
information gathered through the survey
is to determine helpfulness of
participants’ initial contact with Be The
Match® Patient Services Coordinators
(PSC) and to identify areas for
improvement in the delivery of services.
The survey will include items to
measure: (1) Reason for contacting Be
The Match®; (2) if the PSC was able to
answer questions and were easy to
understand; (3) if the contact helped the
participant to feel better prepared to
discuss transplant with their care team;
(4) increase in awareness of available
resources; (5) timeliness of response;
and (6) overall satisfaction. Stakeholders
utilize this evaluation data to make
program and resource allocation
decisions.
Likely Respondents: Respondents will
include all patients, caregivers and
family members who have contact with
Be The Match® Patient Services
Coordinators via phone or email for
transplant navigation services and
support (advocacy). The decision to
survey all participants was made based
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]]>Agencies
[Federal Register Volume 79, Number 157 (Thursday, August 14, 2014)]
[Notices]
[Pages 47655-47656]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-19219]
-----------------------------------------------------------------------
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 September
15, 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:
Federal Tort Claims Act (FTCA) Free Clinic Application OMB No. 0915-
0293--Revision.
Abstract: Under 42 U.S.C. 233(o) and Program Assistance Letter
(PAL) 2014-04, ``Calendar Year 2015 Federal Tort Claims Act (FTCA)
Deeming Application for Free Clinics,'' free clinics are required to
submit annual applications for deeming of qualified health care
professionals, board members, officers, and contractors for purposes of
FTCA medical malpractice coverage for negligent acts and omissions that
arise from the performance of medical, surgical, dental, or related
functions within the scope of the covered individual's deemed
employment. HRSA proposes modifying the application forms to reflect
changes to eligible personnel made by section 10608 of the Affordable
Care Act, which extended FTCA medical malpractice liability protection
to free clinic board members, officers, employees, and contractors.
Additionally, HRSA proposes upgrading the application to provide for
electronic submissions. Specifically, the modifications include: (1)
Inclusion of board members, officers, employees, and contractors into
one comprehensive application that also includes volunteer health care
professionals and (2) a fully electronic application that can be
submitted via HRSA's web-based application system, the Electronic
Handbooks (EHBs). It is anticipated that
[[Page 47656]]
these modifications will decrease the time and effort required to
complete the current OMB approved FTCA application forms.
Need and Proposed Use of the Information: Deemed status for FTCA
medical malpractice coverage requires HRSA approval of an application
for deeming of certain eligible individuals from a sponsoring free
clinic. The FTCA Free Clinic deeming application is an electronic
application submitted to HRSA through the EHBs as part of the process
of deeming qualified health care professionals, board members,
officers, and individual contractors. Sponsoring clinics are required
to submit a completed electronic application in addition to other
required documents as required by section 224(o) of the Public Health
Service Act (42 U.S.C. 233(o)). Applications are reviewed by program
staff before a deeming determination is made.
Likely Respondents: Respondents include nonprofit private entities
that meet the statutory and programmatic requirements as stated in
section 224(o) of the Public Health Service Act (42 U.S.C. 233(o)) and
implementing HRSA policy guidance.
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)
----------------------------------------------------------------------------------------------------------------
FTCA Free Clinics Program 227 1 227 2 681
Application....................
-------------------------------------------------------------------------------
Total....................... 227 1 227 2 681
----------------------------------------------------------------------------------------------------------------
Dated: August 8, 2014.
Jackie Painter,
Acting Director, Division of Policy and Information Coordination.
[FR Doc. 2014-19219 Filed 8-13-14; 8:45 am]
BILLING CODE 4165-15-P
