Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request, 13377-13378 [2016-05602]
Download as PDF
jstallworth on DSK7TPTVN1PROD with NOTICES
Federal Register / Vol. 81, No. 49 / Monday, March 14, 2016 / Notices
eteplirsen injection for intravenous
infusion, sponsored by Sarepta
Therapeutics, Inc., for the treatment of
Duchenne muscular dystrophy (DMD)
in patients who have a confirmed
mutation of the DMD gene that is
amenable to exon 51 skipping.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before April 11, 2016. Oral
presentations from the public will be
scheduled between approximately 12:40
p.m. and 2:40 p.m. Those individuals
interested in making formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before April 1,
2016. Time allotted for each
presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by April 4, 2016.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with disabilities.
If you require accommodations due to a
disability, please contact Moon Hee V.
Choi at least 7 days in advance of the
meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
VerDate Sep<11>2014
14:27 Mar 11, 2016
Jkt 238001
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: March 9, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2016–05683 Filed 3–10–16; 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:
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 April 13, 2016.
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:
SUMMARY:
Information Collection Request Title:
Bureau of Health Workforce
Performance Data Collection
OMB No. 0915–0061—Revision
Abstract: Over 40 Bureau of Health
Workforce (BHW) programs award
grants to health professions schools and
training programs across the United
States to develop, expand, and enhance
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
13377
training, and to strengthen the
distribution of the health workforce.
These programs are authorized by the
Public Health Service Act (42 U.S.C. 201
et seq.), specifically Titles III, VII, and
VIII. Performance information regarding
these programs is collected in the HRSA
Performance Report for Grants and
Cooperative Agreements (PRGCA). Data
collection activities consisting of an
annual progress and annual
performance report satisfy statutory and
programmatic requirements for
performance measurement and
evaluation (including specific Title III,
VII and VIII requirements), as well as
Government Performance and Results
Act (GPRA) requirements. The
performance measures were last revised
in 2013 to ensure they addressed
programmatic changes, met evolving
program management needs, and
responded to emerging workforce
concerns—especially as a result of the
changes in the Affordable Care Act
(Pub. L. 111–148). As these revisions
were successful, BHW will continue to
use the same progress and performance
forms. BHW is reducing the reporting
burden by eliminating the semi-annual
performance report and moving to
annual progress and performance
reporting.
Need and Proposed Use of the
Information: The purpose of the data
collection is to analyze and report
grantee training activities and
education, identify intended practice
locations, and report outcomes of
funded initiatives. Data collected from
these grant programs also provide a
description of the program activities of
approximately 1,700 reporting grantees
to better inform policymakers on the
barriers, opportunities, and outcomes
involved in health care workforce
development. The measures focus on
five key outcomes: (1) Increasing the
workforce supply of diverse welleducated practitioners, (2) increasing
the number of practitioners that practice
in underserved and rural areas, (3)
enhancing the quality of education, (4)
increasing the recruitment, training, and
placement of under-represented groups
in the health workforce, and (5)
supporting educational infrastructure to
increase the capacity to train more
health professionals.
Likely Respondents: Respondents are
awardees of BHW health professions
grant programs.
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
E:\FR\FM\14MRN1.SGM
14MRN1
13378
Federal Register / Vol. 81, No. 49 / Monday, March 14, 2016 / Notices
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
Average
burden per
response
(in hours)
Total
responses
Total burden
hours
Direct Financial Support Program .......................................
Infrastructure Program .........................................................
Multipurpose or Hybrid Program ..........................................
618
149
790
1
1
1
618
149
790
3.117
4.57
4.285
1,926
681
3,385
Total ..............................................................................
1,557
........................
1,557
........................
5,992
Jackie Painter,
Director, Division of the Executive Secretariat.
[FR Doc. 2016–05602 Filed 3–11–16; 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.
AGENCY:
ACTION:
Notice.
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.
SUMMARY:
Comments on this Information
Collection Request must be received
within 60 days of this notice.
DATES:
Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N39, Parklawn
Building, 5600 Fishers Lane, Rockville,
MD 20857.
jstallworth on DSK7TPTVN1PROD with NOTICES
ADDRESSES:
VerDate Sep<11>2014
14:27 Mar 11, 2016
Jkt 238001
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:
Organ Procurement and Transplantation
Network and Scientific Registry of
Transplant Recipients Data System
OMB No. 0915–0157—Revision.
Abstract: Section 372 of the Public
Health Service (PHS) Act, as amended,
requires that the Secretary, by contract,
provide for the establishment and
operation of an Organ Procurement and
Transplantation Network (OPTN). This
is a request for revisions to current
OPTN data collection forms associated
with an individual’s clinical
characteristics at the time of
registration, transplant, and follow-up
after the transplant. These specific data
elements of the OPTN data system are
collected from transplant hospitals. The
information is used to indicate the
disease severity of transplant
candidates, to monitor compliance of
member organizations with OPTN rules
and requirements, to report periodically
on the clinical and scientific status of
organ donation and transplantation and
other purposes consistent with the law.
Data are used to: (1) Facilitate organ
placement and match donor organs with
recipients; (2) monitor compliance of
member organizations with federal laws
and regulations and with OPTN
requirements; (3) review and report
FOR FURTHER INFORMATION CONTACT:
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
periodically to the public on the status
of organ donation and transplantation in
the United States; (4) provide data to
researchers and government agencies to
study the scientific and clinical status of
organ transplantation; and (5) perform
transplantation-related public health
surveillance including possible
transmission of donor disease. The
practical utility of the data collection is
further enhanced by requirements that
the OPTN data must be made available,
consistent with applicable laws, for use
by OPTN members, the Scientific
Registry of Transplant Recipients, the
Department of Health and Human
Services, and members of the public for
evaluation, research, patient
information, and other important
purposes.
Likely Respondents: Transplant
programs, medical and scientific
organizations, and public organizations.
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: (1) Review instructions;
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; (2) train
personnel to respond to a request for
collection of information; (3) search data
sources; (4) complete and review the
collection of information; and (5) to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this Information
Collection Request are summarized in
the table below.
E:\FR\FM\14MRN1.SGM
14MRN1
Agencies
[Federal Register Volume 81, Number 49 (Monday, March 14, 2016)]
[Notices]
[Pages 13377-13378]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-05602]
-----------------------------------------------------------------------
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 April 13,
2016.
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: Bureau of Health Workforce
Performance Data Collection
OMB No. 0915-0061--Revision
Abstract: Over 40 Bureau of Health Workforce (BHW) programs award
grants to health professions schools and training programs across the
United States to develop, expand, and enhance training, and to
strengthen the distribution of the health workforce. These programs are
authorized by the Public Health Service Act (42 U.S.C. 201 et seq.),
specifically Titles III, VII, and VIII. Performance information
regarding these programs is collected in the HRSA Performance Report
for Grants and Cooperative Agreements (PRGCA). Data collection
activities consisting of an annual progress and annual performance
report satisfy statutory and programmatic requirements for performance
measurement and evaluation (including specific Title III, VII and VIII
requirements), as well as Government Performance and Results Act (GPRA)
requirements. The performance measures were last revised in 2013 to
ensure they addressed programmatic changes, met evolving program
management needs, and responded to emerging workforce concerns--
especially as a result of the changes in the Affordable Care Act (Pub.
L. 111-148). As these revisions were successful, BHW will continue to
use the same progress and performance forms. BHW is reducing the
reporting burden by eliminating the semi-annual performance report and
moving to annual progress and performance reporting.
Need and Proposed Use of the Information: The purpose of the data
collection is to analyze and report grantee training activities and
education, identify intended practice locations, and report outcomes of
funded initiatives. Data collected from these grant programs also
provide a description of the program activities of approximately 1,700
reporting grantees to better inform policymakers on the barriers,
opportunities, and outcomes involved in health care workforce
development. The measures focus on five key outcomes: (1) Increasing
the workforce supply of diverse well-educated practitioners, (2)
increasing the number of practitioners that practice in underserved and
rural areas, (3) enhancing the quality of education, (4) increasing the
recruitment, training, and placement of under-represented groups in the
health workforce, and (5) supporting educational infrastructure to
increase the capacity to train more health professionals.
Likely Respondents: Respondents are awardees of BHW health
professions grant programs.
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
[[Page 13378]]
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)
----------------------------------------------------------------------------------------------------------------
Direct Financial Support Program 618 1 618 3.117 1,926
Infrastructure Program.......... 149 1 149 4.57 681
Multipurpose or Hybrid Program.. 790 1 790 4.285 3,385
-------------------------------------------------------------------------------
Total....................... 1,557 .............. 1,557 .............. 5,992
----------------------------------------------------------------------------------------------------------------
Jackie Painter,
Director, Division of the Executive Secretariat.
[FR Doc. 2016-05602 Filed 3-11-16; 8:45 am]
BILLING CODE 4165-15-P