Submission for OMB Review; Refugee Data Submission System for Formula Funds Allocations (ORR-5) (OMB #0970-0043), 70179-70180 [2020-24398]
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Federal Register / Vol. 85, No. 214 / Wednesday, November 4, 2020 / Notices
BILLING CODE 4120–01–C
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review; Refugee
Data Submission System for Formula
Funds Allocations (ORR–5) (OMB
#0970–0043)
Office of Refugee Resettlement,
Administration for Children and
Families, HHS.
AGENCY:
ACTION:
Request for public comment.
The Office of Refugee
Resettlement (ORR), Administration for
Children and Families (ACF), U.S.
Department of Health and Human
Services (HHS), is proposing to extend
approval for data collection using the
current Refugee Data Submission
System for Formula Funds Allocations
(ORR–5) until January 31, 2021, and
revise the current form for use after
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SUMMARY:
VerDate Sep<11>2014
18:16 Nov 03, 2020
Jkt 253001
Fiscal Year (FY) 2020. The revised form
will collect additional client-level data.
DATES: Comments due within 30 days of
publication. OMB must make a decision
about the collection of information
between 30 and 60 days after
publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication.
Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
SUPPLEMENTARY INFORMATION:
Description: ORR–5 is designed to
satisfy the statutory requirements of the
Immigration and Nationality Act (INA).
Section 412(a)(3) of INA (8 U.S.C.
1522(a)(3)) requires that the Director of
ORR make a periodic assessment of the
needs of refugees for assistance and
ADDRESSES:
PO 00000
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Fmt 4703
Sfmt 4703
services and the resources available to
meet those needs. ORR proposes an
extension with no changes to the
current form until January 31, 2021, to
ensure continuous information
collection for FY 2020. ORR also
proposes revisions to the current form
for use after FY 2020. Revisions include
collecting additional client-level data
elements on the ORR–5 at multiple
points in time, which will allow the
ORR Director to better understand client
goals, services utilized, and the
outcomes achieved by the population
ORR serves. New data elements include
additional demographics, primary goals
identified and referrals made to work
toward self-sufficiency, progress made
toward achieving said goals, and
employment status of employable
refugees 12 months post-enrollment.
The data collected will inform evidencebased policy making and program
design. These revisions also enable ORR
and states to monitor implementation of
the requirements put forth in ORR
Policy Letter 19–07.
Respondents: States, Replacement
Designees, and the District of Columbia.
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[FR Doc. 2020–24464 Filed 11–3–20; 8:45 am]
70179
70180
Federal Register / Vol. 85, No. 214 / Wednesday, November 4, 2020 / Notices
ANNUAL BURDEN ESTIMATES
Total number
of respondents
Instrument
Refugee Data Submission for Formula Funds Allocations
(ORR–5)—Current (through January 31, 2021) ..............
Refugee Data Submission for Formula Funds Allocations
(ORR–5)—Revised ...........................................................
Total number
of responses
per respondent
Average
burden hours
per response
Total burden
hours
Annual burden
hours
50
1
90
4,500
* 1,500
50
3
140
21,000
7,000
* Burden is annualized over the full 3-year request period, but this form will be complete within the 1st year.
Estimated Total Annual Burden
Hours: 8,500.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Authority: 8 U.S.C. 412(a)(3).
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2020–24398 Filed 11–3–20; 8:45 am]
BILLING CODE 4184–45–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Exceptions or Alternatives to Labeling
Requirements for Products Held by the
Strategic National Stockpile
Food and Drug Administration
[Docket No. FDA–2010–N–0588]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Exceptions or
Alternatives to Labeling Requirements
for Products Held by the Strategic
National Stockpile
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995
(PRA).
SUMMARY:
Submit written comments
(including recommendations) on the
collection of information by December
4, 2020.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0614. Also include
the FDA docket number found in
brackets in the heading of this
document.
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DATES:
VerDate Sep<11>2014
18:16 Nov 03, 2020
Jkt 253001
OMB Control Number 0910–0614—
Extension
Under the Public Health Service Act,
the Department of Health and Human
Services stockpiles medical products
that are essential to the health security
of the Nation (see 42 U.S.C. 247d–6b).
This collection of medical products for
use during national health emergencies,
known as the Strategic National
Stockpile (SNS), is to provide for the
emergency health security of the United
States, including the emergency health
security of children and other
vulnerable populations, in the event of
a bioterrorist attack or other public
health emergency.
It may be appropriate for certain
medical products that are or will be
held in the SNS to be labeled in a
manner that would not comply with
certain FDA labeling regulations given
their anticipated circumstances of use in
an emergency. However, noncompliance
with these labeling requirements could
render such products misbranded under
section 502 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 352).
Under §§ 201.26, 610.68, 801.128, and
809.11 (21 CFR 201.26, 610.68, 801.128,
and 809.11), the appropriate FDA Center
Director may grant a request for an
exception or alternative to certain
regulatory provisions pertaining to the
labeling of human drugs, biological
products, medical devices, and in vitro
diagnostics that currently are or will be
included in the SNS if certain criteria
are met. The appropriate FDA Center
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Fmt 4703
Sfmt 4703
Director may grant an exception or
alternative to certain FDA labeling
requirements if compliance with these
labeling requirements could adversely
affect the safety, effectiveness, or
availability of products that are or will
be included in the SNS. An exception
or alternative granted under the
regulations may include conditions or
safeguards so that the labeling for such
products includes appropriate
information necessary for the safe and
effective use of the product given the
product’s anticipated circumstances of
use. Any grant of an exception or
alternative will only apply to the
specified lots, batches, or other units of
medical products in the request. The
appropriate FDA Center Director may
also grant an exception or alternative to
the labeling provisions specified in the
regulations on his or her own initiative.
Under §§ 201.26(b)(1)(i) (human drug
products), 610.68(b)(1)(i) (biological
products), 801.128(b)(1)(i) (medical
devices), and 809.11(b)(1)(i) (in vitro
diagnostic products for human use) an
SNS official or any entity that
manufactures (including labeling,
packing, relabeling, or repackaging),
distributes, or stores such products that
are or will be included in the SNS may
submit, with written concurrence from
a SNS official, a written request for an
exception or alternative to certain
labeling requirements to the appropriate
FDA Center Director. Except when
initiated by an FDA Center Director, a
request for an exception or alternative
must be in writing and must:
• Identify the specified lots, batches,
or other units of the affected product;
• identify the specific labeling
provisions under the regulations that are
the subject of the request;
• explain why compliance with the
specified labeling provisions could
adversely affect the safety, effectiveness,
or availability of the product subject to
the request;
• describe any proposed safeguards or
conditions that will be implemented so
that the labeling of the product includes
appropriate information necessary for
the safe and effective use of the product
E:\FR\FM\04NON1.SGM
04NON1
]]>Agencies
[Federal Register Volume 85, Number 214 (Wednesday, November 4, 2020)]
[Notices]
[Pages 70179-70180]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-24398]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Refugee Data Submission System for
Formula Funds Allocations (ORR-5) (OMB #0970-0043)
AGENCY: Office of Refugee Resettlement, Administration for Children and
Families, HHS.
ACTION: Request for public comment.
-----------------------------------------------------------------------
SUMMARY: The Office of Refugee Resettlement (ORR), Administration for
Children and Families (ACF), U.S. Department of Health and Human
Services (HHS), is proposing to extend approval for data collection
using the current Refugee Data Submission System for Formula Funds
Allocations (ORR-5) until January 31, 2021, and revise the current form
for use after Fiscal Year (FY) 2020. The revised form will collect
additional client-level data.
DATES: Comments due within 30 days of publication. OMB must make a
decision about the collection of information between 30 and 60 days
after publication of this document in the Federal Register. Therefore,
a comment is best assured of having its full effect if OMB receives it
within 30 days of publication.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.
SUPPLEMENTARY INFORMATION:
Description: ORR-5 is designed to satisfy the statutory
requirements of the Immigration and Nationality Act (INA). Section
412(a)(3) of INA (8 U.S.C. 1522(a)(3)) requires that the Director of
ORR make a periodic assessment of the needs of refugees for assistance
and services and the resources available to meet those needs. ORR
proposes an extension with no changes to the current form until January
31, 2021, to ensure continuous information collection for FY 2020. ORR
also proposes revisions to the current form for use after FY 2020.
Revisions include collecting additional client-level data elements on
the ORR-5 at multiple points in time, which will allow the ORR Director
to better understand client goals, services utilized, and the outcomes
achieved by the population ORR serves. New data elements include
additional demographics, primary goals identified and referrals made to
work toward self-sufficiency, progress made toward achieving said
goals, and employment status of employable refugees 12 months post-
enrollment. The data collected will inform evidence-based policy making
and program design. These revisions also enable ORR and states to
monitor implementation of the requirements put forth in ORR Policy
Letter 19-07.
Respondents: States, Replacement Designees, and the District of
Columbia.
[[Page 70180]]
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Total number Average burden
Instrument Total number of responses hours per Total burden Annual burden
of respondents per respondent response hours hours
----------------------------------------------------------------------------------------------------------------
Refugee Data Submission for 50 1 90 4,500 * 1,500
Formula Funds Allocations (ORR-
5)--Current (through January
31, 2021)......................
Refugee Data Submission for 50 3 140 21,000 7,000
Formula Funds Allocations (ORR-
5)--Revised....................
----------------------------------------------------------------------------------------------------------------
* Burden is annualized over the full 3-year request period, but this form will be complete within the 1st year.
Estimated Total Annual Burden Hours: 8,500.
Authority: 8 U.S.C. 412(a)(3).
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2020-24398 Filed 11-3-20; 8:45 am]
BILLING CODE 4184-45-P
