Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Radiation Exposure Screening and Education Program, OMB No. 0906-0012-Extension, 68889-68890 [2020-24122]
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Federal Register / Vol. 85, No. 211 / Friday, October 30, 2020 / Notices
68889
Application No.
Drug
Applicant
ANDA 210681 ......................
Ranitidine HCl Capsules, EQ 150 mg base and EQ 300
mg base.
Novitium Pharma LLC, 70 Lake Dr., East Windsor, NJ
08520.
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of November 30,
2020. Approval of each entire
application is withdrawn, including any
strengths and dosage forms
inadvertently missing from the table.
Introduction or delivery for introduction
into interstate commerce of products
without approved new drug
applications violates section 301(a) and
(d) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331(a) and (d)).
Drug products that are listed in the table
that are in inventory on November 30,
2020 may continue to be dispensed
until the inventories have been depleted
or the drug products have reached their
expiration dates or otherwise become
violative, whichever occurs first.
Dated: October 26, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–24012 Filed 10–29–20; 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: Radiation
Exposure Screening and Education
Program, OMB No. 0906–0012—
Extension
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
SUMMARY:
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 December 29,
2020.
Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, MD 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:
Radiation Exposure Screening and
Education Program, OMB No. 0906–
0012—Extension.
Abstract: The Radiation Exposure
Screening and Education Program
(RESEP) is authorized by section 417C
of the Public Health Service Act (42
U.S.C. 285a–9). The purpose of RESEP
is to assist individuals who live (or
lived) in areas where U.S. nuclear
weapons testing occurred and who are
diagnosed with cancer and other
radiogenic diseases caused by exposure
to nuclear fallout or nuclear materials
such as uranium. RESEP funds support
eligible health care organizations in:
Implementing cancer screening
programs; developing education
programs; disseminating information on
radiogenic diseases and the importance
of early detection; screening eligible
individuals for cancer and other
ADDRESSES:
radiogenic diseases; providing
appropriate referrals for medical
treatment; and facilitating
documentation of Radiation Exposure.
Need and Proposed Use of the
Information: For this program,
performance measures were drafted to
provide data useful to the program and
to enable HRSA to provide aggregate
program data required by Congress
under the Government Performance and
Results Act of 1993 (Pub. L. 103–62).
These measures cover the principal
topic areas of interest to the Federal
Office of Rural Health Policy, including:
(a) Demographics for the RESEP
program user population; (b) medical
screening activities for cancers and
other radiogenic diseases; (c) exposure
and presentation types for eligible
radiogenic malignant and nonmalignant
diseases; (d) referrals for appropriate
medical treatment; (e) eligibility
counseling and referral assistance for
the RECA; and (f) program outreach and
education activities. These measures
will speak to the Office’s progress
toward meeting the goals set.
Likely Respondents: Radiation
Exposure Screening and Education
Program award recipients.
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.
jbell on DSKJLSW7X2PROD with NOTICES
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Radiation Expose Screening and Education Program ........
VerDate Sep<11>2014
21:10 Oct 29, 2020
Jkt 253001
Number of
responses per
respondent
Number of
respondents
Form name
PO 00000
Frm 00057
8
8
Fmt 4703
1
........................
Sfmt 4703
Average
burden per
response
(in hours)
Total
responses
E:\FR\FM\30OCN1.SGM
8
8
30OCN1
12
........................
Total burden
hours
96
96
68890
Federal Register / Vol. 85, No. 211 / Friday, October 30, 2020 / Notices
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, Executive Secretariat.
[FR Doc. 2020–24122 Filed 10–29–20; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Ninth Meeting of the National Clinical
Care Commission
Office on Women’s Health,
Office of the Assistant Secretary for
Health, Office of the Secretary,
Department of Health and Human
Services.
ACTION: Notice.
AGENCY:
The National Clinical Care
Commission (the Commission) will
conduct its ninth meeting virtually on
November 17, 2020. The Commission is
charged to evaluate and make
recommendations to the U.S.
Department of Health and Human
Services (HHS) Secretary and Congress
regarding improvements to the
coordination and leveraging of federal
programs related to diabetes and its
complications.
DATES: The meeting will take place on
November 17, 2020, from 1 p.m. to
approximately 5:30 p.m. Eastern
Standard time (EST).
ADDRESSES: The meeting will be held
online via webinar. To register to attend
the meeting, please visit the registration
website at https://
kauffmaninc.adobeconnect.com/nccc_
9/event/event_info.html.
FOR FURTHER INFORMATION CONTACT:
Clydette Powell, M.D., M.P.H., F.A.A.P.,
Designated Federal Officer, National
Clinical Care Commission, U.S.
Department of Health and Human
Services, Office on Women’s Health,
200 Independence Ave. SW 7th Floor,
Washington DC 20201. Phone: (240)
453–8239. Email: OHQ@hhs.gov.
SUPPLEMENTARY INFORMATION: The
National Clinical Care Commission Act
(Pub. L. 115–80) requires the HHS
Secretary to establish the National
Clinical Care Commission. The
Commission consists of representatives
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
21:10 Oct 29, 2020
Jkt 253001
of specific federal agencies and nonfederal individuals who represent
diverse disciplines and views. The
Commission will evaluate and make
recommendations to the HHS Secretary
and Congress regarding improvements
to the coordination and leveraging of
federal programs related to diabetes and
its complications.
The ninth meeting will be held
virtually and will consist of updates
from the Commission’s three
subcommittees and a discussion of
public comments and outreach to
stakeholder organizations. Additionally,
the Commission will discuss the second
round of potential ‘‘action plans’’ from
the subcommittees (i.e.,
recommendations). The final meeting
agenda will be available prior to the
meeting at https://health.gov/our-work/
health-care-quality/national-clinicalcare-commission/meetings.
Public Participation at Meeting: The
Commission invites public comment on
issues related to the Commission’s
charge. There will be an opportunity for
limited oral comments (each no more
than 3 minutes in length) at this virtual
meeting. Virtual attendees who plan to
provide oral comments at the
Commission meeting during a
designated time must register prior to
the meeting at https://
kauffmaninc.adobeconnect.com/nccc_
9/event/event_info.html.
Written comments are welcome
throughout the entire development
process of the Commission’s work and
may be emailed to OHQ@hhs.gov.
Written comments should not exceed
three pages in length.
Individuals who need special
assistance, such as sign language
interpretation or other reasonable
accommodations, should indicate the
special accommodation when
registering online or by notifying
Jennifer Gillissen at jennifer.gillissen@
kauffmaninc.com by November 9, 2020.
Authority: The National Clinical Care
Commission is required under the National
Clinical Care Commission Act (Pub. L. 115–
80). The Commission is governed by
provisions of the Federal Advisory
Committee Act (FACA), Public Law 92–463,
as amended (5 U.S.C., App.) which sets forth
standards for the formation and use of federal
advisory committees.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; 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 contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; Small Business Innovation
Research (SBIR) Phase II Program Contract
Solicitation (PHS 2019–1) Topic 74.
Date: November 24, 2020.
Time: 10:00 a.m. to 1:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3G62A,
Rockville, MD 20892, Bethesda, MD (Virtual
Meeting).
Contact Person: Eleazar Cohen, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
National Institute of Allergy and Infectious
Diseases, National Institutes of Health, 5601
Fishers Lane, Room 3G62A, Bethesda, MD
20892, (240) 669–5081, ecohen@
niaid.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: October 26, 2020.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–24081 Filed 10–29–20; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: October 27, 2020.
Dorothy Fink,
Deputy Assistant Secretary for Women’s
Health, Office of the Assistant Secretary for
Health.
National Institutes of Health
[FR Doc. 2020–24126 Filed 10–29–20; 8:45 am]
AGENCY:
BILLING CODE 4150–32–P
HHS.
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
Final NIH Policy for Data Management
and Sharing and Supplemental
Information
E:\FR\FM\30OCN1.SGM
National Institutes of Health,
30OCN1
]]>Agencies
[Federal Register Volume 85, Number 211 (Friday, October 30, 2020)]
[Notices]
[Pages 68889-68890]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-24122]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Public Comment Request; Information Collection Request Title: Radiation
Exposure Screening and Education Program, OMB No. 0906-0012--Extension
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 December
29, 2020.
ADDRESSES: Submit your comments to [email protected] or mail the HRSA
Information Collection Clearance Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, MD 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: Radiation Exposure Screening
and Education Program, OMB No. 0906-0012--Extension.
Abstract: The Radiation Exposure Screening and Education Program
(RESEP) is authorized by section 417C of the Public Health Service Act
(42 U.S.C. 285a-9). The purpose of RESEP is to assist individuals who
live (or lived) in areas where U.S. nuclear weapons testing occurred
and who are diagnosed with cancer and other radiogenic diseases caused
by exposure to nuclear fallout or nuclear materials such as uranium.
RESEP funds support eligible health care organizations in: Implementing
cancer screening programs; developing education programs; disseminating
information on radiogenic diseases and the importance of early
detection; screening eligible individuals for cancer and other
radiogenic diseases; providing appropriate referrals for medical
treatment; and facilitating documentation of Radiation Exposure.
Need and Proposed Use of the Information: For this program,
performance measures were drafted to provide data useful to the program
and to enable HRSA to provide aggregate program data required by
Congress under the Government Performance and Results Act of 1993 (Pub.
L. 103-62). These measures cover the principal topic areas of interest
to the Federal Office of Rural Health Policy, including: (a)
Demographics for the RESEP program user population; (b) medical
screening activities for cancers and other radiogenic diseases; (c)
exposure and presentation types for eligible radiogenic malignant and
nonmalignant diseases; (d) referrals for appropriate medical treatment;
(e) eligibility counseling and referral assistance for the RECA; and
(f) program outreach and education activities. These measures will
speak to the Office's progress toward meeting the goals set.
Likely Respondents: Radiation Exposure Screening and Education
Program award recipients.
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)
----------------------------------------------------------------------------------------------------------------
Radiation Expose Screening and 8 1 8 12 96
Education Program..............
8 .............. 8 .............. 96
----------------------------------------------------------------------------------------------------------------
[[Page 68890]]
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, Executive Secretariat.
[FR Doc. 2020-24122 Filed 10-29-20; 8:45 am]
BILLING CODE 4165-15-P
