Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals, 24867-24868 [2021-09811]
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Federal Register / Vol. 86, No. 88 / Monday, May 10, 2021 / Notices
data. Please note that comments
received, including attachments and
other supporting materials, are part of
the public record and are subject to
public disclosure. Comments will be
posted on https://www.regulations.gov.
Therefore, do not include any
information in your comment or
supporting materials that you consider
confidential or inappropriate for public
disclosure. If you include your name,
contact information, or other
information that identifies you in the
body of your comments, that
information will be on public display.
CDC will review all submissions and
may choose to redact, or withhold,
submissions containing private or
proprietary information such as Social
Security numbers, medical information,
inappropriate language, or duplicate/
near duplicate examples of a mass-mail
campaign. CDC will carefully consider
all comments submitted into the docket.
Written Public Comment: Written
comments must be received on or before
May 12, 2021.
Oral Public Comment: This meeting
will include time for members of the
public to make an oral comment. Oral
public comment will occur before any
scheduled votes including all votes
relevant to the ACIP’s Affordable Care
Act and Vaccines for Children Program
roles. Priority will be given to
individuals who submit a request to
make an oral public comment before the
meeting according to the procedures
below.
Procedure for Oral Public Comment:
All persons interested in making an oral
public comment at the May 12, 2021
ACIP meeting must submit a request at
https://www.cdc.gov/vaccines/acip/
meetings/ no later than 11:59 p.m., EDT,
May 10, 2021 according to the
instructions provided.
If the number of persons requesting to
speak is greater than can be reasonably
accommodated during the scheduled
time, CDC will conduct a lottery to
determine the speakers for the
scheduled public comment session.
CDC staff will notify individuals
regarding their request to speak by email
by 12:00 p.m., EDT, May 11, 2021. To
accommodate the significant interest in
participation in the oral public
comment session of ACIP meetings,
each speaker will be limited to 3
minutes, and each speaker may only
speak once per meeting.
The Director, Strategic Business
Initiatives Unit, Office of the Chief
Operating Officer, Centers for Disease
Control and Prevention, has been
delegated the authority to sign Federal
Register notices pertaining to
announcements of meetings and other
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committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Kalwant Smagh,
Director, Strategic Business Initiatives Unit,
Office of the Chief Operating Officer, Centers
for Disease Control and Prevention.
[FR Doc. 2021–09893 Filed 5–6–21; 11:15 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
[CFDA Number: 93.676]
Announcement of Intent To Issue
Multiple Single-Source Awards To
Provide Residential (Shelter) and
Transitional Foster Care Services, and
for Finger Print Services for
Unaccompanied Children
Office of Refugee Resettlement
(ORR), Administration for Children and
Families (ACF), Department of Health
and Human Services (HHS).
ACTION: Notice of issuance of multiple
single-source awards to seven
recipients.
AGENCY:
ACF, ORR announces the
issuance of multiple Single-Source
Awards to seven recipients in the
amount of $65,366,800. ORR has been
identifying additional permanent
capacity to provide shelter for recent
increases in apprehensions of
Unaccompanied Children (UC) at the
Southwest Border. The addition of
permanent capacity is a prudent step to
ensure that ORR is able to meet its
responsibility, by law, to provide shelter
and appropriate services for UC referred
to its care by the Department of
Homeland Security.
DATES: The proposed period of
performance is May 1, 2021 to May 1,
2022.
FOR FURTHER INFORMATION CONTACT:
Stephen Antkowiak, Office of Refugee
Resettlement, Division of
Unaccompanied Alien Children
Operations, 330 Street SW, Washington,
DC 20447. Phone: 202–260–6165. Email:
stephen.antkowiak@acf.hhs.gov.
SUPPLEMENTARY INFORMATION: ORR is
continuously monitoring its capacity to
shelter the UC referred to HHS, as well
as the information received from
interagency partners, to inform any
future decisions or actions.
ORR has specific requirements for the
provision of services. Award recipients
must have the infrastructure, licensing,
SUMMARY:
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experience, and appropriate level of
trained staff to meet those requirements.
ORR announces the intent to award
the following single-source awards:
Recipient
Award
amount
Child Crisis, Mesa, AZ ................
Catholic Guardian Services, New
York, NY ..................................
Center for Family Services,
Camden, NJ ............................
LIRS—Shelter/TFC, Multiple Locations .....................................
Baptiste Group, Memphis, TN ....
Bethany Christian Service, Multiple Locations .........................
LIRS—Safe Release Expansion,
Multiple Locations ...................
$5,780,118
5,183,433
1,665,980
27,767,725
14,135,642
7,018,576
3,815,326
Statutory Authority: This program is
authorized by—
(A) Section 462 of the Homeland
Security Act of 2002, which in March
2003, transferred responsibility for the
care and custody of UAC from the
Commissioner of the former
Immigration and Naturalization Service
to the Director of ORR within HHS.
(B) The Flores Settlement Agreement,
Case No. CV85–4544RJK (C.D. Cal.
1996), as well as the William
Wilberforce Trafficking Victims
Protection Reauthorization Act of 2008
(Pub. L. 110–457), which authorizes
post release services under certain
conditions to eligible children. All
programs must comply with the Flores
Settlement Agreement, Case No. CV85–
4544–RJK (C.D. Cal. 1996); pertinent
regulations; and ORR policies and
procedures.
Elizabeth Leo,
Senior Grants Policy Specialist, Office of
Grants Policy, Office of Administration.
[FR Doc. 2021–09758 Filed 5–4–21; 4:15 pm]
BILLING CODE 4184–45–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2020–N–2030; FDA–
2017–N–4951; FDA–2017–N–5569; FDA–
2020–N–1652; FDA–2017–N–7012; and
FDA–2019–N–4763]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is publishing a
list of information collections that have
SUMMARY:
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24868
Federal Register / Vol. 86, No. 88 / Monday, May 10, 2021 / Notices
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(PRA).
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
following is a list of FDA information
collections recently approved by OMB
under section 3507 of the PRA (44
U.S.C. 3507). The OMB control number
and expiration date of OMB approval for
each information collection are shown
in table 1. Copies of the supporting
statements for the information
collections are available on the internet
at https://www.reginfo.gov/public/do/
PRAMain. An Agency may not conduct
or sponsor, and a person is not required
to respond to, a collection of
information unless it displays a
currently valid OMB control number.
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB control
No.
Title of collection
Applications for FDA Approval to Market a New Drug ...........................................................................................
Medical Devices; Humanitarian Use Devices .........................................................................................................
Medical Devices; Device Tracking ..........................................................................................................................
Dispute Resolution Procedures for Science Based Decision on Products Regulated by CVM .............................
Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based
In Vitro Diagnostics ..............................................................................................................................................
Assessment of Terms and Phrases Commonly Used in Prescription Drug Promotion .........................................
Dated: May 4, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–09811 Filed 5–7–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2021–N–0387]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Recommended
Content of Medical Product
Communications That Are Consistent
With the Food and Drug
Administration-Required Labeling and
Recommendations for Drug and
Device Manufacturer Communications
With Payors, Formulary Committees,
and Similar Entities
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the information
collection associated with
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SUMMARY:
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recommended content of medical
product communications that are
consistent with the FDA-required
labeling and recommendations for drug
and device manufacturer
communications with payors, formulary
committees, and similar entities.
DATES: Submit either electronic or
written comments on the collection of
information by July 9, 2021.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before July 9, 2021.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of July 9, 2021. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
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Date approval
expires
0910–0001
0910–0332
0910–0442
0910–0566
3/31/2024
3/31/2024
3/31/2024
3/31/2024
0910–0850
0910–0895
3/31/2024
3/31/2024
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2021–N–0387 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Recommended Content of Medical
Product Communications That Are
Consistent With the FDA-Required
Labeling and Recommendations for
Drug and Device Manufacturer
Communications With Payors,
Formulary Committees, and Similar
Entities.’’ Received comments, those
filed in a timely manner (see
ADDRESSES), will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
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[Federal Register Volume 86, Number 88 (Monday, May 10, 2021)]
[Notices]
[Pages 24867-24868]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-09811]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2020-N-2030; FDA-2017-N-4951; FDA-2017-N-5569; FDA-
2020-N-1652; FDA-2017-N-7012; and FDA-2019-N-4763]
Agency Information Collection Activities; Announcement of Office
of Management and Budget Approvals
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
information collections that have
[[Page 24868]]
been approved by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA).
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[email protected].
SUPPLEMENTARY INFORMATION: The following is a list of FDA information
collections recently approved by OMB under section 3507 of the PRA (44
U.S.C. 3507). The OMB control number and expiration date of OMB
approval for each information collection are shown in table 1. Copies
of the supporting statements for the information collections are
available on the internet at https://www.reginfo.gov/public/do/PRAMain.
An Agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently
valid OMB control number.
Table 1--List of Information Collections Approved by OMB
------------------------------------------------------------------------
OMB control Date approval
Title of collection No. expires
------------------------------------------------------------------------
Applications for FDA Approval to Market 0910-0001 3/31/2024
a New Drug.............................
Medical Devices; Humanitarian Use 0910-0332 3/31/2024
Devices................................
Medical Devices; Device Tracking........ 0910-0442 3/31/2024
Dispute Resolution Procedures for 0910-0566 3/31/2024
Science Based Decision on Products
Regulated by CVM.......................
Use of Public Human Genetic Variant 0910-0850 3/31/2024
Databases to Support Clinical Validity
for Genetic and Genomic-Based In Vitro
Diagnostics............................
Assessment of Terms and Phrases Commonly 0910-0895 3/31/2024
Used in Prescription Drug Promotion....
------------------------------------------------------------------------
Dated: May 4, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-09811 Filed 5-7-21; 8:45 am]
BILLING CODE 4164-01-P
