Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: Data Collection Tool for State Offices of Rural Health Grant Program, OMB No. 0915-0322-Revision, 31073-31074 [2019-13804]
Download as PDF
<![CDATA[
Federal Register / Vol. 84, No. 125 / Friday, June 28, 2019 / Notices
to assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Ellis
Unger, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 4212, Silver Spring,
MD 20993–0002, 301–796–2240 or
Stephen Ripley, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Treatment for Heart Failure: Endpoints
for Drug Development.’’ Heart failure
causes substantial mortality and
morbidity and has major effects on
physical function and quality of life.
This draft guidance clarifies that an
effect on symptoms or physical
function, without a favorable effect on
survival or hospitalization, can be a
basis for approving drugs to treat heart
failure. It also provides
recommendations to sponsors on the
need to assess mortality effects of drugs
under development to treat heart failure.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Treatment for Heart Failure:
Endpoints for Drug Development.’’ It
does not establish any rights for any
person and is not binding on FDA or the
public. You can use an alternative
approach if it satisfies the requirements
of the applicable statutes and
regulations. This guidance is not subject
to Executive Order 12866.
khammond on DSKBBV9HB2PROD with NOTICES
II. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520).
FDA has OMB approval under the
PRA for the submission of INDs,
including protocol amendments and
information amendments, in 21 CFR
part 312, subpart B, and sponsors may
request comment and advice on an IND
as well as request meetings with FDA
under subpart C (OMB control number
0910–0014). In addition, the following
VerDate Sep<11>2014
17:41 Jun 27, 2019
Jkt 247001
collections of information that have
been approved by OMB would cover
other submissions discussed in the draft
guidance:
• Guidance for industry on formal
meetings with sponsors and applicants
for Prescription Drug User Fee Act
products (OMB control number 0910–
0429);
• Guidance for industry on clinical
trial data monitoring committees (OMB
control number 0910–0581);
• Guidance for industry on oversight
of clinical investigations (OMB control
number 0910–0733);
• International Council for
Harmonization guidance for industry
‘‘E6(R2) Good Clinical Practice’’ (OMB
control number 0910–0843);
• Protection of Human Subjects:
Informed Consent; Institutional Review
Boards (21 CFR parts 50 and 56) (OMB
control number 0910–0755); and
• Institutional Review Boards
(§ 56.115) (OMB control number 0910–
0130).
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics, or https://
www.regulations.gov.
Dated: June 24, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–13800 Filed 6–27–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request Information
Collection Request Title: Data
Collection Tool for State Offices of
Rural Health Grant Program, OMB No.
0915–0322—Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
SUMMARY:
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
31073
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 ICR should be
received no later than August 27, 2019.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, Maryland 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 Lisa Wright-Solomon, 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:
Data Collection Tool for State Offices of
Rural Health Grant Program, OMB No.
0915–0322—Revision
Abstract: The mission of the Federal
Office of Rural Health Policy (FORHP)
is to sustain and improve access to
quality care services for rural
communities. In its authorizing
language (Section 711 of the Social
Security Act [42 U.S.C. 912]), Congress
charged FORHP with administering
grants, cooperative agreements, and
contracts to provide technical assistance
and other activities as necessary to
support activities related to improving
health care in rural areas. In accordance
with the Public Health Service Act,
Section 338J (42 U.S.C. 254r), HRSA
proposes to continue the State Offices of
Rural Health (SORH) Grant Program
data collection process.
Need and Proposed Use of the
Information: FORHP seeks to continue
gathering information from grantees on
their efforts to provide technical
assistance to clients within their state.
SORH grantees submit a Technical
Assistance Report that includes: (1) The
total number of technical assistance
encounters provided directly by the
grantee, and (2) the total number of
unduplicated clients that received direct
technical assistance from the grantee.
These measures will continue with
additional measures being added in the
following three categories: (1)
Information disseminated, (2)
information created, and (3)
collaborative efforts by topic area and
type of audience. These proposed new
measures are being added to obtain a
E:\FR\FM\28JNN1.SGM
28JNN1
31074
Federal Register / Vol. 84, No. 125 / Friday, June 28, 2019 / Notices
more accurate depiction of the breadth
of SORH work and are based on
recommendations from the grantees.
Submission of the Technical Assistance
Report is required via the HRSA
Electronic Handbook no later than 30
days after the end of each 12 month
budget period.
Likely Respondents: Fifty State
Offices of Rural Health.
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
Average
burden per
response
(in hours)
Total
responses
Total
burden
hours
Technical Assistance Report ...............................................
50
1
50
13.5
675
Total ..............................................................................
50
........................
50
........................
675
HRSA 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.
Maria G. Button,
Director, Division of the Executive Secretariat.
[FR Doc. 2019–13804 Filed 6–27–19; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Advisory Council on Alzheimer’s
Research, Care, and Services; Meeting
Assistant Secretary for
Planning and Evaluation, HHS.
ACTION: Notice of meeting.
AGENCY:
This notice announces the
public meeting of the Advisory Council
on Alzheimer’s Research, Care, and
Services (Advisory Council). The
Advisory Council on Alzheimer’s
Research, Care, and Services provides
advice on how to prevent or reduce the
burden of Alzheimer’s disease and
related dementias on people with the
disease and their caregivers. The
Advisory Council will spend the
majority of time during the July 29, 2019
meeting considering recommendations
made by each of the three
subcommittees to present to the
Secretary of HHS and Congress.
Additional presentations will include
SUMMARY:
khammond on DSKBBV9HB2PROD with NOTICES
Number of
responses per
respondent
VerDate Sep<11>2014
17:41 Jun 27, 2019
Jkt 247001
updates on the latest biomedical
research findings, an overview of the
Healthy Brain Initiative: The Road Map
for Indian Country, and a discussion of
the progress made since 2011 through
the National Plan to Address
Alzheimer’s Disease. Federal
workgroups will also provide updates.
DATES: The meeting will be held on July
29, 2019 from 9 a.m. to 4:30 p.m. EST.
ADDRESSES: The meeting will be held in
Room 800 in the Hubert H. Humphrey
Building, 200 Independence Avenue
SW, Washington, DC 20201.
Comments: Time is allocated on the
agenda to hear public comments. The
time for oral comments will be limited
to two (2) minutes per individual. In
lieu of oral comments, formal written
comments may be submitted for the
record to Helen Lamont, Ph.D., OASPE,
200 Independence Avenue SW, Room
424E, Washington, DC 20201.
Comments may also be sent to napa@
hhs.gov. Those submitting written
comments should identify themselves
and any relevant organizational
affiliations.
FOR FURTHER INFORMATION CONTACT:
Helen Lamont, 202–260–6075,
helen.lamont@hhs.gov. Note: Seating
may be limited. Those wishing to attend
the meeting must send an email to
napa@hhs.gov and put ‘‘July 29 Meeting
Attendance’’ in the subject line by
Friday, July 19 so that their names may
be put on a list of expected attendees
and forwarded to the security officers at
the Department of Health and Human
Services. Any interested member of the
public who is a non-U.S. citizen should
include this information at the time of
registration to ensure that the
appropriate security procedure to gain
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
entry to the building is carried out.
Although the meeting is open to the
public, procedures governing security
and the entrance to Federal buildings
may change without notice. If you wish
to make a public comment, you must
note that within your email.
Notice of
these meetings is given under the
Federal Advisory Committee Act (5
U.S.C. App. 2, section 10(a)(1) and
(a)(2)). Topics of the Meeting: The July
29, 2019 meeting of the Advisory
Council will focus on considering
recommendations made by each of the
three subcommittees to present to the
Secretary of HHS and Congress. There
will also be updates on the latest
biomedical research findings, an
overview of the Healthy Brain Initiative:
The Road Map for Indian Country, and
a discussion of the progress made since
2011 through the National Plan to
Address Alzheimer’s Disease.
SUPPLEMENTARY INFORMATION:
Procedure and Agenda: This meeting
is open to the public. Please allow 30
minutes to go through security and walk
to the meeting room. The meeting will
also be webcast at www.hhs.gov/live.
Authority: 42 U.S.C. 11225; Section 2(e)(3)
of the National Alzheimer’s Project Act. The
panel is governed by provisions of Public
Law 92–463, as amended (5 U.S.C. Appendix
2), which sets forth standards for the
formation and use of advisory committees.
Dated: June 24, 2019.
Brenda Destro,
Deputy Assistant Secretary for Planning and
Evaluation, Office of Human Services Policy.
[FR Doc. 2019–13850 Filed 6–27–19; 8:45 am]
BILLING CODE 4150–15–P
E:\FR\FM\28JNN1.SGM
28JNN1
]]>Agencies
[Federal Register Volume 84, Number 125 (Friday, June 28, 2019)]
[Notices]
[Pages 31073-31074]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-13804]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Public Comment Request Information Collection Request Title: Data
Collection Tool for State Offices of Rural Health Grant Program, OMB
No. 0915-0322--Revision
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement for opportunity for public
comment on proposed data collection projects of the Paperwork Reduction
Act of 1995, 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 ICR should be received no later than August 27,
2019.
ADDRESSES: Submit your comments to [email protected] or mail the HRSA
Information Collection Clearance Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, Maryland 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 [email protected] or call Lisa Wright-
Solomon, 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: Data Collection Tool for
State Offices of Rural Health Grant Program, OMB No. 0915-0322--
Revision
Abstract: The mission of the Federal Office of Rural Health Policy
(FORHP) is to sustain and improve access to quality care services for
rural communities. In its authorizing language (Section 711 of the
Social Security Act [42 U.S.C. 912]), Congress charged FORHP with
administering grants, cooperative agreements, and contracts to provide
technical assistance and other activities as necessary to support
activities related to improving health care in rural areas. In
accordance with the Public Health Service Act, Section 338J (42 U.S.C.
254r), HRSA proposes to continue the State Offices of Rural Health
(SORH) Grant Program data collection process.
Need and Proposed Use of the Information: FORHP seeks to continue
gathering information from grantees on their efforts to provide
technical assistance to clients within their state. SORH grantees
submit a Technical Assistance Report that includes: (1) The total
number of technical assistance encounters provided directly by the
grantee, and (2) the total number of unduplicated clients that received
direct technical assistance from the grantee. These measures will
continue with additional measures being added in the following three
categories: (1) Information disseminated, (2) information created, and
(3) collaborative efforts by topic area and type of audience. These
proposed new measures are being added to obtain a
[[Page 31074]]
more accurate depiction of the breadth of SORH work and are based on
recommendations from the grantees. Submission of the Technical
Assistance Report is required via the HRSA Electronic Handbook no later
than 30 days after the end of each 12 month budget period.
Likely Respondents: Fifty State Offices of Rural Health.
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 burden
Form name Number of responses per Total per response Total burden
respondents respondent responses (in hours) hours
----------------------------------------------------------------------------------------------------------------
Technical Assistance Report..... 50 1 50 13.5 675
-------------------------------------------------------------------------------
Total....................... 50 .............. 50 .............. 675
----------------------------------------------------------------------------------------------------------------
HRSA 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.
Maria G. Button,
Director, Division of the Executive Secretariat.
[FR Doc. 2019-13804 Filed 6-27-19; 8:45 am]
BILLING CODE 4165-15-P
