Submission for OMB Review; Refugee Data Submission System for Formula Funds Allocations (ORR-5) (OMB #0970-0043), 70179-70180 [2020-24398]

Download as PDF 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 khammond on DSKJM1Z7X2PROD with NOTICES 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 Frm 00053 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. E:\FR\FM\04NON1.SGM 04NON1 EN04NO20.031</GPH> [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. khammond on DSKJM1Z7X2PROD with NOTICES 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 PO 00000 Frm 00054 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]


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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