Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Data Collection Tool for State Offices of Rural Health Grant Program, OMB No. 0915-0322-Revision, 67275-67276 [2019-26440]
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Federal Register / Vol. 84, No. 236 / Monday, December 9, 2019 / Notices
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
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Submit written requests for single
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0002. Send one self-addressed adhesive
label 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access to the draft guidance document.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: Anil
Nayyar, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave, Bldg. 22, Rm. 5170, Silver Spring,
MD 20993–0002, 301–796–7969.
SUPPLEMENTARY INFORMATION:
khammond on DSKJM1Z7X2PROD with NOTICES
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs or https://
www.regulations.gov.
Dated: December 4, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
BILLING CODE 4164–01–P
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Development of Locally Applied
Corticosteroid Products for the ShortTerm Treatment of Symptoms
Associated with Internal or External
Hemorrhoids.’’ This draft guidance
addresses the recommended attributes
of patients for enrollment, efficacy
assessments, safety assessments, and
additional considerations with respect
to development programs and clinical
trials for drugs aimed at the short-term
treatment of symptoms associated with
internal and external hemorrhoids.
This draft guidance is being issued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The draft guidance, when finalized, will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 ‘‘Development of Locally Applied
Corticosteroid Products for the ShortTerm Treatment of Symptoms
Associated with Internal and External
17:22 Dec 06, 2019
II. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information that
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). The collection of
information in 21 CFR part 312 have
been approved under OMB control
number 0910–0014. The collection of
information for the protection of human
subjects, informed consent, and
Institutional Review Boards in 21 CFR
parts 50 and 56 have been approved
under OMB control numbers 0910–0755
and 0910–0130. The information
collection resulting from ‘‘GFI: Clinical
Trial Data Monitoring Committees’’ has
been approved under OMB control
number 0910–0581. The information
collection in the ‘‘Oversight of Clinical
Investigations: A Risk-Based Approach
to Monitoring’’ has been approved
under OMB control number 0910–0733.
[FR Doc. 2019–26464 Filed 12–6–19; 8:45 am]
I. Background
VerDate Sep<11>2014
Hemorrhoids.’’ 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.
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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; 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
Paperwork Reduction Act of 1995,
HRSA has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
SUMMARY:
PO 00000
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67275
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. OMB may act on
HRSA’s ICR only after the 30-day
comment period for this Notice has
closed.
DATES: Comments on this ICR should be
received no later than January 8, 2020.
ADDRESSES: Submit your comments,
including the ICR 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 Lisa
Wright-Solomon, the HRSA Information
Collection Clearance Officer at
paperwork@hrsa.gov or call (301) 443–
1984.
SUPPLEMENTARY INFORMATION:
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.
A 60-day notice published in the
Federal Register on June 28, 2019, vol.
84, No. 125; pp. 31073–74. There were
no public comments.
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
E:\FR\FM\09DEN1.SGM
09DEN1
67276
Federal Register / Vol. 84, No. 236 / Monday, December 9, 2019 / Notices
type of audience. These proposed new
measures are being added to obtain a
more accurate depiction of the breadth
of SORH work and are based on
recommendations from the grantees.
Submission of the Technical Assistance
Report is submitted 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
Total
responses
Average
burden per
response
(in hours)
Total
burden
hours
Technical Assistance Report ...............................................
50
1
50
13.5
675
Total ..............................................................................
50
........................
50
........................
675
Maria G. Button,
Director, Executive Secretariat.
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Tick-Borne Disease
Working Group
Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
AGENCY:
ACTION:
Notice.
As required by the Federal
Advisory Committee Act, the
Department of Health and Human
Services (HHS) is hereby giving notice
that the Tick-Borne Disease Working
Group (TBDWG) will hold a meeting.
The meeting will be open to the public.
For this meeting, the TBDWG will (1)
hear presentations from eight
subcommittees on findings and
potential actions from reports prepared
for the TBDWG to consider and (2)
further discuss plans for developing the
next report to the HHS Secretary and
Congress on federal tick-borne activities
and research, taking into consideration
the 2018 report. The 2020 report will
address ongoing tick-borne disease
research, including research related to
causes, prevention, treatment,
surveillance, diagnosis, diagnostics,
duration of illness, and intervention for
individuals with tick-borne diseases;
advances made pursuant to such
research; federal activities related to
tick-borne diseases; and gaps in tickborne disease research.
SUMMARY:
VerDate Sep<11>2014
17:22 Dec 06, 2019
The meeting will be held on
January 28–29, 2020, from 9:00 a.m. to
4:30 p.m. ET (times are tentative and
subject to change). The confirmed times
and agenda items for the meeting will be
posted on the website for the TBDWG at
https://www.hhs.gov/ash/advisorycommittees/tickbornedisease/meetings/
2020-1-28/ when this
information becomes available.
ADDRESSES: The meeting will be held at
Hyatt Place Washington DC/US Capitol,
33 New York Avenue NE, Washington,
DC 20002. Members of the public may
also attend the meeting via webcast.
Instructions for attending via webcast
will be posted one week prior to the
meeting at https://www.hhs.gov/ash/
advisory-committees/tickbornedisease/
meetings/2020-1-28/.
FOR FURTHER INFORMATION CONTACT:
James Berger, Designated Federal Officer
for the TBDWG; Office of Infectious
Disease and HIV/AIDS Policy, Office of
the Assistant Secretary for Health,
Department of Health and Human
Services, Mary E Switzer Building, 330
C Street SW, Suite L600, Washington,
DC 20024. Email: tickbornedisease@
hhs.gov; Phone: 202–795–7608.
SUPPLEMENTARY INFORMATION: In-person
attendance at the meeting is limited to
space available; therefore,
preregistration for public members is
advisable and can be accomplished by
registering at https://
www.eventbrite.com/e/tick-bornedisease-working-group-meeting-january28-29-2020-meeting-11-tickets81603750013. On the day of the
meeting, seating will be provided first to
persons who have preregistered. People
who have not preregistered will be
accommodated on a first come, first
served basis if additional seats are still
DATES:
[FR Doc. 2019–26440 Filed 12–6–19; 8:45 am]
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
responses per
respondent
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available 10 minutes before the meeting
starts. Non-U.S. citizens who plan to
attend in person are required to provide
additional information and must notify
the Working Group support staff via
email at tickbornedisease@hhs.gov
before December 28, 2019.
The public will have an opportunity
to present their views orally to the
TBDWG during the meeting’s public
comment session or by submitting a
written public comment. Comments
should be pertinent to the meeting
discussion. Persons who wish to
provide verbal or written public
comment should review instructions at
https://www.hhs.gov/ash/advisorycommittees/tickbornedisease/meetings/
2020-1-28/ and respond by
midnight Tuesday, January 17, 2020,
ET. Verbal comments will be limited to
three minutes each to accommodate as
many speakers as possible during the
two 30 minute sessions. Written public
comments will be accessible to the
TBDWG members and made public on
the TBDWG web page prior to the
meeting.
Background and Authority: The TickBorne Disease Working Group was
established on August 10, 2017, in
accordance with Section 2062 of the
21st Century Cures Act, and the Federal
Advisory Committee Act, 5 U.S.C. App.,
as amended, to provide expertise and
review federal efforts related to all tickborne diseases, to help ensure
interagency coordination and minimize
overlap, and to examine research
priorities. The TBDWG is required to
submit a report to the HHS Secretary
and Congress on their findings and any
recommendations for the federal
response to tick-borne disease every two
years.
E:\FR\FM\09DEN1.SGM
09DEN1
]]>Agencies
[Federal Register Volume 84, Number 236 (Monday, December 9, 2019)]
[Notices]
[Pages 67275-67276]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-26440]
-----------------------------------------------------------------------
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; 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 Paperwork Reduction Act of 1995, 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. OMB may act on HRSA's ICR only after the 30-day
comment period for this Notice has closed.
DATES: Comments on this ICR should be received no later than January 8,
2020.
ADDRESSES: Submit your comments, including the ICR Title, to the desk
officer for HRSA, either by email to [email protected] 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 Lisa Wright-Solomon, the
HRSA Information Collection Clearance Officer at [email protected] or
call (301) 443-1984.
SUPPLEMENTARY INFORMATION:
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.
A 60-day notice published in the Federal Register on June 28, 2019,
vol. 84, No. 125; pp. 31073-74. There were no public comments.
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
[[Page 67276]]
type of audience. These proposed new measures are being added to obtain
a more accurate depiction of the breadth of SORH work and are based on
recommendations from the grantees. Submission of the Technical
Assistance Report is submitted 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
----------------------------------------------------------------------------------------------------------------
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2019-26440 Filed 12-6-19; 8:45 am]
BILLING CODE 4165-15-P
