Attachment 3 60_Day_FRN_published_2019

Federal Register / Vol. 84, No. 142 / Wednesday, July 24, 2019 / Notices
To send a check by a courier such as
Federal Express, the courier must
deliver the check and printed copy of
the cover sheet to: U.S. Bank, Attn:
Government Lockbox 979108, 1005
Convention Plaza, St. Louis, MO 63101.
(Note: This address is for courier
delivery only. If you have any questions
concerning courier delivery, contact
U.S. Bank at 314–418–4013. This phone
number is only for questions about
courier delivery.)
The tax identification number of FDA
is 53–0196965. (Note: In no case should
the payment for the fee be submitted to
FDA with the invoice.)
V. What are the consequences of not
paying this fee?

Dated: July 19, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–15742 Filed 7–23–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES

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Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request Information
Collection Request Title: Health Center
Patient Survey, OMB No. 0915–0368—
Reinstatement
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).

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Notice.

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 September 23,
2019.
SUMMARY:

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, 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 Center Patient Survey, OMB No.
0915–0368—Reinstatement
Abstract: The Health Center Program,
administered by HRSA, is authorized
under section 330 of the Public Health
Service Act, most recently amended by
section 50901(b) of the Bipartisan
Budget Act of 2018, Public Law 115–
123. Health centers are communitybased and patient-directed organizations
that deliver affordable, accessible,
quality, and cost-effective primary
health care services to patients
regardless of their ability to pay. Nearly
1,400 health centers operate
approximately 12,000 service delivery
sites that provide primary health care to
more than 27 million people in every
U.S. state, the District of Columbia,
Puerto Rico, the U.S. Virgin Islands, and
the Pacific Basin. In the past, HRSA has
conducted the Health Center Patient
Survey (HCPS), which surveys patients
of HRSA-supported health centers. The
HCPS collects information about
sociodemographic characteristics,
health conditions, health behaviors,
access to and utilization of health care
ADDRESSES:

The consequences of not paying these
fees are outlined in Section J of ‘‘FDA’s
Voluntary Qualified Importer Program;
Guidance for Industry’’ document
(available at https://www.fda.gov/
media/92196/download). If the user fee
is not paid before October 1, a VQIP
importer will not be eligible to
participate in VQIP. For the first year a
VQIP application is approved, if the
user fee is not paid before October 1,
2019, you are not eligible to participate
in VQIP. If you subsequently pay the
user fee, FDA will begin your benefits
after we receive the full payment. The
user fee may not be paid after December
31, 2019. For a subsequent year, if you
do not pay the user fee before October
1, FDA will send a Notice of Intent to
Revoke your participation in VQIP. If
you do not pay the user fee within 30
days of the date of the Notice of Intent
to Revoke, we will revoke your
participation in VQIP.

AGENCY:

ACTION:

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services, and satisfaction with health
care received at HRSA-supported health
centers. The reinstatement of the HCPS
will utilize the same modules from the
2014 HCPS (OMB #0915–0368).
Overarching improvements to the
survey instrument will streamline the
questionnaire to minimize burden and
standardize questions with other
national surveys to enable comparative
analyses with a particular focus on HHS
and HRSA priority areas (e.g., mental
health and substance use). Survey
results come from in-person, one-on-one
interviews with patients who are
selected as nationally representative of
the Health Center Program patient
population.
Need and Proposed Use of the
Information: The HCPS is unique
because it focuses on comprehensive,
nationally representative, individual
level data from the perspective of health
center patients. By investigating how
well HRSA-supported health centers
meet health care needs of the medically
underserved and how patients perceive
their quality of care, the HCPS serves as
an empirically based resource to inform
HRSA policy, funding, and planning
decisions.
Likely Respondents: Patients at
HRSA-supported health centers.
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. Compared to the previous
HCPS, the estimated burden hours for
an individual respondent remain the
same in this reinstatement. However,
the total annual burden hours and
number of survey respondents is
anticipated to increase in order to reflect
the growing number of patients served
by the Health Center Program. The total
annual burden hours estimated for this
ICR are summarized in the table below.

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Federal Register / Vol. 84, No. 142 / Wednesday, July 24, 2019 / Notices
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
NATIONAL STUDY
Number of
respondents

Form name

Total
responses

Average
burden per
response
(in hours)

Total
burden
hours

Grantee Recruitment ............................................................
Site Recruitment and Training .............................................
Patient Screening .................................................................
Patient Survey ......................................................................

220
700
13,120
9,058

1
1
1
1

220
700
13,120
9,058

2.00
3.15
.17
1.25

440.00
2,205.00
2,230.40
11,322.50

Total National Study .....................................................

23,098

........................

23,098

........................

16,197.90

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. 2019–15699 Filed 7–23–19; 8:45 am]
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National Institutes of Health

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National Cancer Institute; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Cancer
Institute Special Emphasis Panel; Feasibility
and Planning Studies for SPOREs to
Investigate Cancer Health Disparities (P20).
Date: September 25, 2019.
Time: 10:00 a.m. to 1:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute Shady
Grove, 9609 Medical Center Drive, Room

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7W618, Rockville, MD 20850 (Telephone
Conference Call).
Contact Person: Mukesh Kumar, Ph.D.,
Scientific Review Officer, Research Program
Review Branch, Division of Extramural
Activities, 9609 Medical Center Drive, Room
7W618, National Cancer Institute, NIH,
Rockville, MD 20850, 240–276–6611,
[email protected].
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS)
Dated: July 19, 2019.
Program Analyst, Office of Federal Advisory
Committee Policy.

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

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Number of
responses per
respondent

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections 552b(c)
(4) and 552b(c) (6), Title 5 U.S.C., as
amended. The purpose of this meeting
is to evaluate requests for preclinical
development resources for potential
new therapeutics for the treatment of
cancer. The outcome of the evaluation
will provide information to internal NCI
committees that will decide whether
NCI should support requests and make
available contract resources for
development of the potential
therapeutic to improve the treatment of
various forms of cancer. The research
proposals and the discussions could

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disclose confidential trade secrets or
commercial property such as patentable
material, and personal information
concerning individuals associated with
the proposed research projects, the
disclosure of which would constitute a
clearly unwarranted invasion of
personal privacy.
Name of Committee: National Cancer
Institute Special Emphasis Panel;
JUN2019 Cycle 31 NExT SEP Committee
Meeting.
Date: August 8, 2019.
Time: 9:00 a.m. to 3:00 p.m.
Agenda: To evaluate the NCI
Experimental Therapeutics Program
Portfolio.
Place: National Institutes of Health,
9000 Rockville Pike, Building 35A,
Room 35, Bethesda, MD 20892.
Contact Persons: Barbara
Mroczkowski, Ph.D., Executive
Secretary, Discovery Experimental
Therapeutics Program, National Cancer
Institute, NIH, 31 Center Drive, Room
3A44, Bethesda, MD 20817, (301) 496–
4291, [email protected].
Toby Hecht, Ph.D., Executive
Secretary, Development Experimental
Therapeutics Program, National Cancer
Institute, NIH, 9609 Medical Center
Drive, Room 3W110, Rockville, MD
20850, (240) 276–5683, toby.hecht2@
nih.gov.
(Catalogue of Federal Domestic
Assistance Program Nos. 93.392, Cancer
Construction; 93.393, Cancer Cause and
Prevention Research; 93.394, Cancer
Detection and Diagnosis Research;
93.395, Cancer Treatment Research;
93.396, Cancer Biology Research;
93.397, Cancer Centers Support; 93.398,
Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of
Health, HHS)
Dated: July 19, 2019.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2019–15734 Filed 7–23–19; 8:45 am]
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