Submission for OMB Review; Comment Request, 53160-53161 [2015-21727]

Download as PDF 53160 Federal Register / Vol. 80, No. 170 / Wednesday, September 2, 2015 / Notices ANNUAL BURDEN ESTIMATES Number of respondents Instrument Youth Outcome Survey ................................................................................... Data File .......................................................................................................... 20,667 52 Estimated Total Annual Burden Hours: 202,630. DEPARTMENT OF HEALTH AND HUMAN SERVICES Additional Information Administration for Children and Families 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, DC 20447, Attn: ACF Reports Clearance Officer. All requests should be identified by the title of the information collection. Email address: infocollection@acf.hhs.gov. 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: OIRA_SUBMISSION@ OMB.EOP.GOV. Attn: Desk Officer for the Administration for Children and Families. Robert Sargis, Reports Clearance Officer. [FR Doc. 2015–21728 Filed 9–1–15; 8:45 am] BILLING CODE 4184–01–P Number of responses per respondent 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 Average burden hours per response 1 2 0.50 1,849 Total burden hours 10,334 192,296 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 mstockstill on DSK4VPTVN1PROD with NOTICES Instrument Number of respondents Number of responses per respondent Average burden hours per response Total burden hours Refugee Data Submission for Formula Funds Allocations ............................. 50 1 20 1,000 Estimated Total Annual Burden Hours: 1,000. VerDate Sep<11>2014 19:04 Sep 01, 2015 Jkt 235001 Additional Information: Copies of the proposed collection may be obtained by writing to the Administration for PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 Children and Families, Office of Planning, Research and Evaluation, 370 L’Enfant Promenade SW., Washington, E:\FR\FM\02SEN1.SGM 02SEN1 Federal Register / Vol. 80, No. 170 / Wednesday, September 2, 2015 / Notices DC 20447, Attn: ACF Reports Clearance Officer. All requests should be identified by the title of the information collection. Email address: infocollection@acf.hhs.gov. 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: OIRA_SUBMISSION@ OMB.EOP.GOV, Attn: Desk Officer for the Administration for Children and Families. Robert Sargis, Reports Clearance Officer. BILLING CODE 4184–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2011–D–0164] Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Safety Labeling Changes— Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the 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 requirement to make safety related labeling changes based upon new safety information that becomes available after the drug or biological product is approved under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) or the Public Health Service Act (PHS Act.) mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 19:04 Sep 01, 2015 Submit electronic comments on the collection of information to: http:// www.regulations.gov. Submit written comments on the collection of information to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. ADDRESSES: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. FOR FURTHER INFORMATION CONTACT: Under the PRA (44 U.S.C. 3501–3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ‘‘Collection of information’’ is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. With respect to the following collection of information, FDA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility; (2) the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. SUPPLEMENTARY INFORMATION: [FR Doc. 2015–21727 Filed 9–1–15; 8:45 am] AGENCY: Submit either electronic or written comments on the collection of information by November 2, 2015. DATES: Jkt 235001 PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 53161 Guidance for Industry on Safety Labeling Changes—Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act (OMB Control Number 0910–0734)—Extension Section 505(o)(4) of the FD&C Act (21 U.S.C. 355(o)(4)) authorizes FDA to require, and if necessary, order labeling changes if FDA becomes aware of new safety information that FDA believes should be included in the labeling of certain prescription drug and biological products approved under section 505 of the FD&C Act or section 351 of the PHS Act (42 U.S.C. 262). Section 505(o)(4) of the FD&C Act applies to prescription drug products with an approved new drug application (NDA) under section 505(b) of the FD&C Act, biological products with an approved biologics license application under section 351 of the PHS Act, or prescription drug products with an approved abbreviated new drug application under section 505(j) of the FD&C Act if the reference listed drug with an approved NDA is not currently marketed. Section 505(o)(4) imposes timeframes for application holders to submit and FDA staff to review such changes, and gives FDA new enforcement tools to bring about timely and appropriate labeling changes. The guidance provides information on the implementation of the new provisions, including a description of the types of safety labeling changes that ordinarily might be required under the new legislation, how FDA plans to determine what constitutes new safety information, the procedures involved in requiring safety labeling changes, and enforcement of the requirements for safety labeling changes. FDA requires safety labeling changes by sending a notification letter to the application holder. Under section 505(o)(4)(B), the application holder must respond to FDA’s notification by submitting a labeling supplement or notifying FDA that the applicant does not believe the labeling change is warranted and submitting a statement detailing the reasons why the application holder does not believe a change is warranted (a rebuttal statement). Based on FDA’s experience to date with safety labeling changes requirements under section 505(o)(4), we estimate that approximately 42 application holders will elect to submit approximately one rebuttal statement each year and that each rebuttal statement will take approximately 6 hours to prepare. In addition, in the guidance, FDA states that new labeling prepared in E:\FR\FM\02SEN1.SGM 02SEN1

Agencies

[Federal Register Volume 80, Number 170 (Wednesday, September 2, 2015)]
[Notices]
[Pages 53160-53161]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: 
infocollection@acf.hhs.gov.
    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: OIRA_SUBMISSION@OMB.EOP.GOV, 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