80 FR 53160 - Submission for OMB Review; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families

Federal Register Volume 80, Issue 170 (September 2, 2015)

Page Range		53160-53161
FR Document		2015-21727

Federal Register, Volume 80 Issue 170 (Wednesday, September 2, 2015)

[Federal Register Volume 80, Number 170 (Wednesday, September 2, 2015)]
[Notices]
[Pages 53160-53161]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-21727]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Administration for Children and Families


Submission for OMB Review; Comment Request

    Title: Refugee Data Submission System for Formula Funds Allocations
    OMB No.: 0970-0043.
    Description: The information collection of Refugee Data Submission 
System for Formula Funds Allocations replaces the ORR-11 Refugee State 
of Origin Report and is designed to satisfy the statutory requirements 
of the Immigration and Nationality Act (INA). Section 412(a)(3)of the 
Act requires the Director of the Office of Refugee Resettlement (ORR) 
to make a periodic assessment, based on refugee population and other 
relevant factors, of the relative needs of refugees for assistance and 
services and the resources available to meet those needs. This includes 
compiling and maintaining data on the secondary migration of refugees 
within the United States after arrival. Further, INA 412(c)(1)(B)states 
that formula funds shall be allocated based on the total number of 
refugees, taking into account secondary migration.
    In order to meet the statutory requirements, ORR requires each 
state to submit disaggregated individual records containing certain 
data elements for eligible refugee populations. This revised collection 
differs from the ORR-11 Refugee State-of-Origin Report process, whereby 
states submitted the ORR-11 form containing aggregate data on the 
number of refugees and entrants served whose ``area numbers'' (the 
first three digits of the social security number) fell into each of 
several designated numerical ranges. ORR used the information on the 
ORR-11 to measure secondary migration for the purposes of formula funds 
allocation to states. The revision is proposed due to the realization 
that:
    (1) The Social Security Administration states that the first three 
digits of social security numbers (area number) should not be used for 
any other purpose than as an individual identifier for book-keeping 
purposes.
    (2) It is possible for individuals to apply for social security 
numbers from any social security office, not just offices in the state 
in which they were born or first resided. This is particularly likely 
in metropolitan statistical areas where individuals may live in one of 
several states (e.g., the Washington Metropolitan Area). In these 
cases, the area number of the social security number may be unreliable 
as a measure of refugees' state of initial resettlement.
    (3) In recent years, the Social Security Administration has begun 
to issue social security numbers whose area number is not connected to 
any specific state.
    The submission of individual records via the Refugee Data 
Submission System for Formula Funds Allocations Web site is a more 
reliable and secure process for collecting data for the purposes of 
tracking secondary migration and allocating formula funds. Data 
submitted by the States via the secure Web site are compiled and 
analyzed by the ORR statistician for the purpose of refugee secondary 
services formula funds allocation. The statistician also prepares a 
summary report, which is included in ORR's Annual Report to Congress.
    Respondents: States and the District of Columbia.

                                             Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
                                                                  Number of      Average burden
                 Instrument                      Number of      responses per      hours per       Total burden
                                                respondents       respondent        response          hours
----------------------------------------------------------------------------------------------------------------
Refugee Data Submission for Formula Funds                 50                1               20            1,000
 Allocations................................
----------------------------------------------------------------------------------------------------------------

    Estimated Total Annual Burden Hours: 1,000.
    Additional Information: Copies of the proposed collection may be 
obtained by writing to the Administration for Children and Families, 
Office of Planning, Research and Evaluation, 370 L'Enfant Promenade 
SW., Washington,

[[Page 53161]]

DC 20447, Attn: ACF Reports Clearance Officer. All requests should be 
identified by the title of the information collection. Email address: 
[email protected].
    OMB Comment: OMB is required to make a decision concerning 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 directly to the following: Office 
of Management and Budget, Paperwork Reduction Project, Fax: 202-395-
7285, Email: [email protected], Attn: Desk Officer for the 
Administration for Children and Families.

Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2015-21727 Filed 9-1-15; 8:45 am]
 BILLING CODE 4184-01-P

Federal Register / Vol. 80, No. 170 / Wednesday, September 2, 2015 / Notices 53161

DC 20447, Attn: ACF Reports Clearance DATES: Submit either electronic or Guidance for Industry on Safety
Officer. All requests should be written comments on the collection of Labeling Changes—Implementation of
identified by the title of the information information by November 2, 2015. Section 505(o)(4) of the Federal Food,
collection. Email address: Drug, and Cosmetic Act (OMB Control
infocollection@acf.hhs.gov. ADDRESSES: Submit electronic Number 0910–0734)—Extension
OMB Comment: OMB is required to comments on the collection of
information to: http:// Section 505(o)(4) of the FD&C Act (21
make a decision concerning the U.S.C. 355(o)(4)) authorizes FDA to
collection of information between 30 www.regulations.gov. Submit written
comments on the collection of require, and if necessary, order labeling
and 60 days after publication of this changes if FDA becomes aware of new
document in the Federal Register. information to the Division of Dockets
safety information that FDA believes
Therefore, a comment is best assured of Management (HFA–305), Food and Drug
should be included in the labeling of
having its full effect if OMB receives it Administration, 5630 Fishers Lane, Rm.
certain prescription drug and biological
within 30 days of publication. Written 1061, Rockville, MD 20852. All products approved under section 505 of
comments and recommendations for the comments should be identified with the the FD&C Act or section 351 of the PHS
proposed information collection should docket number found in brackets in the Act (42 U.S.C. 262). Section 505(o)(4) of
be sent directly to the following: Office heading of this document. the FD&C Act applies to prescription
of Management and Budget, Paperwork drug products with an approved new
FOR FURTHER INFORMATION CONTACT: FDA
Reduction Project, Fax: 202–395–7285, drug application (NDA) under section
Email: OIRA_SUBMISSION@ PRA Staff, Office of Operations, Food
and Drug Administration, 8455 505(b) of the FD&C Act, biological
OMB.EOP.GOV, Attn: Desk Officer for products with an approved biologics
the Administration for Children and Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@ license application under section 351 of
Families. the PHS Act, or prescription drug
fda.hhs.gov.
Robert Sargis, products with an approved abbreviated
Reports Clearance Officer. SUPPLEMENTARY INFORMATION: Under the new drug application under section
[FR Doc. 2015–21727 Filed 9–1–15; 8:45 am] PRA (44 U.S.C. 3501–3520), Federal 505(j) of the FD&C Act if the reference
Agencies must obtain approval from the listed drug with an approved NDA is
BILLING CODE 4184–01–P
Office of Management and Budget not currently marketed. Section
(OMB) for each collection of 505(o)(4) imposes timeframes for
DEPARTMENT OF HEALTH AND information they conduct or sponsor. application holders to submit and FDA
HUMAN SERVICES ‘‘Collection of information’’ is defined staff to review such changes, and gives
in 44 U.S.C. 3502(3) and 5 CFR FDA new enforcement tools to bring
Food and Drug Administration about timely and appropriate labeling
1320.3(c) and includes Agency requests
changes. The guidance provides
or requirements that members of the
[Docket No. FDA–2011–D–0164] information on the implementation of
public submit reports, keep records, or
the new provisions, including a
provide information to a third party. description of the types of safety
Agency Information Collection Section 3506(c)(2)(A) of the PRA (44
Activities; Proposed Collection; labeling changes that ordinarily might
U.S.C. 3506(c)(2)(A)) requires Federal be required under the new legislation,
Comment Request; Guidance for
Agencies to provide a 60-day notice in how FDA plans to determine what
Industry on Safety Labeling Changes—
Implementation of Section 505(o)(4) of the Federal Register concerning each constitutes new safety information, the
the Federal Food, Drug, and Cosmetic proposed collection of information, procedures involved in requiring safety
Act including each proposed extension of an labeling changes, and enforcement of
existing collection of information, the requirements for safety labeling
AGENCY: Food and Drug Administration, before submitting the collection to OMB changes.
HHS. for approval. To comply with this FDA requires safety labeling changes
ACTION: Notice. requirement, FDA is publishing notice by sending a notification letter to the
of the proposed collection of application holder. Under section
SUMMARY: The Food and Drug information set forth in this document. 505(o)(4)(B), the application holder
Administration (FDA) is announcing an must respond to FDA’s notification by
With respect to the following
opportunity for public comment on the submitting a labeling supplement or
collection of information, FDA invites
proposed collection of certain notifying FDA that the applicant does
comments on: (1) Whether the proposed
information by the Agency. Under the not believe the labeling change is
Paperwork Reduction Act of 1995 (the collection of information is necessary
warranted and submitting a statement
PRA), Federal Agencies are required to for the proper performance of FDA’s
detailing the reasons why the
publish notice in the Federal Register functions, including whether the
application holder does not believe a
concerning each proposed collection of information will have practical utility; change is warranted (a rebuttal
information, including each proposed (2) the accuracy of FDA’s estimate of the statement).
extension of an existing collection of burden of the proposed collection of Based on FDA’s experience to date
information, and to allow 60 days for information, including the validity of with safety labeling changes
public comment in response to the the methodology and assumptions used; requirements under section 505(o)(4),
(3) ways to enhance the quality, utility,
mstockstill on DSK4VPTVN1PROD with NOTICES

notice. This notice solicits comments on we estimate that approximately 42
the requirement to make safety related and clarity of the information to be application holders will elect to submit
labeling changes based upon new safety collected; and (4) ways to minimize the approximately one rebuttal statement
information that becomes available after burden of the collection of information each year and that each rebuttal
the drug or biological product is on respondents, including through the statement will take approximately 6
approved under the Federal Food, Drug, use of automated collection techniques, hours to prepare.
and Cosmetic Act (the FD&C Act) or the when appropriate, and other forms of In addition, in the guidance, FDA
Public Health Service Act (PHS Act.) information technology. states that new labeling prepared in

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Document Created: 2018-02-26 10:10:42
Document Modified: 2018-02-26 10:10:42

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
FR Citation		80 FR 53160

80 FR 53160 - Submission for OMB Review; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICESAdministration for Children and Families

Federal Register Volume 80, Issue 170 (September 2, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families