Submission for OMB Review; Comment Request, 80773-80774 [2015-32580]

Download as PDF 80773 Federal Register / Vol. 80, No. 248 / Monday, December 28, 2015 / Notices ANNUAL BURDEN ESTIMATES Number of respondents Instruments Number of responses per respondent Average burden hours per response Total burden hours § 1305.4(l) Eligibility determination records (sample form) ............................. § 1305.4(d)(2) ................................................................................................... § 1305.4(h),(i), and (j) ...................................................................................... § 1305.4(l) Other Record Keeping ................................................................... 1,600 20 1,600 1,600 478 1 1 1 .10 2 15 15 76,480 40 24,000 24,000 Estimated Total Annual Burden Hours ..................................................... ........................ ........................ ........................ 124,520 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, 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. 2015–32565 Filed 12–24–15; 8:45 am] BILLING CODE 4184–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Submission for OMB Review; Comment Request Title: Refugee Microenterprise and Refugee Home-Based Child Care Microenterprise Development. OMB No.: 0970. Description: New data collection tool for refugee microenterprise and Refugee Home-Based Child Care Microenterprise Program. Respondents: Refugee Microenterprise Development Grantees and Refugee Home-Based Child Care Microenterprise Development. ANNUAL BURDEN ESTIMATES Number of respondents Instrument Number of responses per respondent Average burden hours per response Total burden hours Refugee Microenterprise Development ........................................................... Refugee Home-Based Child Care Microenterprise Development ................... 22 23 8 7 4 4 88 92 Total Burden ............................................................................................. ........................ ........................ ........................ 180 Estimated Total Annual Burden Hours: (180 hours × $30 per hour) $4,500 per year. Explanation mstockstill on DSK4VPTVN1PROD with NOTICES The Refugee Microenterprise Development Program • Currently, there are twenty two grantees (respondents) in the program and the semi-annual progress, which includes the data and information required, is submitted twice per year. • The request covers one form (Form I. attached) which includes eight data points. Based on experience (the information was provided by technical assistance service provider in the past), it takes about two hours per respondent per six months (i.e., four hours per year per grantee (respondent) or 88 hours per year for all respondents) to complete the form. VerDate Sep<11>2014 13:31 Dec 24, 2015 Jkt 238001 • No survey will be undertaken since the collection of this data (information) is part of the implementation process of the project and its collection and reporting does not constitute a separate and additional cost to the grantees (respondents). The cost is covered by the grant the grantee receives. The grantees have Down Home database which captures and stores the data required for reporting. The grantee uploads the semi-annual report in Grant Solution where it is stored. ORR derives the data it requires for reporting and management decision from Grant Solution. The Refugee Home-Based Child Care Microenterprise Development Group • Currently, there are twenty three grantees (respondents) in the program and the semi-annual progress. PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 • The request covers one form (Form II. attached) which includes seven data points. It takes about two hours per respondent per six months (i.e., four hours per year grantee (respondent) or 92 hours per year for all respondents) to complete the form. • The collection of this data (information) is part of the process and its collection and reporting does not include separate and additional cost to the grantees (respondents). The cost is covered by the grant the grantee receives. The grantees have database which captures and stores the data required for reporting. The grantee uploads the data required in Grant Solution where it is stored. ORR derives the data it requires for reporting and management decision from Grant Solution. E:\FR\FM\28DEN1.SGM 28DEN1 80774 Federal Register / Vol. 80, No. 248 / Monday, December 28, 2015 / Notices 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, 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, Email: OIRA_ SUBMISSION@OMB.EOP.GOV. Attn: Desk Officer for the Administration for Children and Families. Robert Sargis, Reports Clearance Officer. [FR Doc. 2015–32580 Filed 12–24–15; 8:45 am] BILLING CODE 4184–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2013–E–1692 and FDA– 2013–E–1691] Determination of Regulatory Review Period for Purposes of Patent Extension; KADCYLA AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) has determined the regulatory review period for KADCYLA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product. DATES: Anyone with knowledge that any of the dates as published (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by February 26, 2016. mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 13:31 Dec 24, 2015 Jkt 238001 Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by June 27, 2016. See ‘‘Petitions’’ in the SUPPLEMENTARY INFORMATION section for more information. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http:// 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 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 http://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): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Division of Dockets Management, 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 Nos. FDA– 2013–E–1692 and FDA–2013–E–1691 for ‘‘Determination of Regulatory Review Period for Purposes of Patent Extension; KADCYLA’’. Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions’’, publicly viewable at PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION’’. The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential’’. Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/ regulatoryinformation/dockets/ default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301–796–3600. SUPPLEMENTARY INFORMATION: I. Background The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98–417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100–670) generally provide that a patent may be extended for a period of up to 5 years E:\FR\FM\28DEN1.SGM 28DEN1

Agencies

[Federal Register Volume 80, Number 248 (Monday, December 28, 2015)]
[Notices]
[Pages 80773-80774]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-32580]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Administration for Children and Families


Submission for OMB Review; Comment Request

    Title: Refugee Microenterprise and Refugee Home-Based Child Care 
Microenterprise Development.
    OMB No.: 0970.
    Description: New data collection tool for refugee microenterprise 
and Refugee Home-Based Child Care Microenterprise Program.
    Respondents: Refugee Microenterprise Development Grantees and 
Refugee Home-Based Child Care Microenterprise Development.

                                             Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
                   Instrument                        Number of     responses per     hours per     Total burden
                                                    respondents     respondent       response          hours
----------------------------------------------------------------------------------------------------------------
Refugee Microenterprise Development.............              22               8               4              88
Refugee Home-Based Child Care Microenterprise                 23               7               4              92
 Development....................................
                                                 ---------------------------------------------------------------
    Total Burden................................  ..............  ..............  ..............             180
----------------------------------------------------------------------------------------------------------------

    Estimated Total Annual Burden Hours: (180 hours x $30 per hour) 
$4,500 per year.

Explanation

The Refugee Microenterprise Development Program
     Currently, there are twenty two grantees (respondents) in 
the program and the semi-annual progress, which includes the data and 
information required, is submitted twice per year.
     The request covers one form (Form I. attached) which 
includes eight data points. Based on experience (the information was 
provided by technical assistance service provider in the past), it 
takes about two hours per respondent per six months (i.e., four hours 
per year per grantee (respondent) or 88 hours per year for all 
respondents) to complete the form.
     No survey will be undertaken since the collection of this 
data (information) is part of the implementation process of the project 
and its collection and reporting does not constitute a separate and 
additional cost to the grantees (respondents). The cost is covered by 
the grant the grantee receives. The grantees have Down Home database 
which captures and stores the data required for reporting. The grantee 
uploads the semi-annual report in Grant Solution where it is stored. 
ORR derives the data it requires for reporting and management decision 
from Grant Solution.
The Refugee Home-Based Child Care Microenterprise Development Group
     Currently, there are twenty three grantees (respondents) 
in the program and the semi-annual progress.
     The request covers one form (Form II. attached) which 
includes seven data points. It takes about two hours per respondent per 
six months (i.e., four hours per year grantee (respondent) or 92 hours 
per year for all respondents) to complete the form.
     The collection of this data (information) is part of the 
process and its collection and reporting does not include separate and 
additional cost to the grantees (respondents). The cost is covered by 
the grant the grantee receives. The grantees have database which 
captures and stores the data required for reporting. The grantee 
uploads the data required in Grant Solution where it is stored. ORR 
derives the data it requires for reporting and management decision from 
Grant Solution.

[[Page 80774]]

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, 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, Email: 
OIRA_SUBMISSION@OMB.EOP.GOV. Attn: Desk Officer for the Administration 
for Children and Families.

Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2015-32580 Filed 12-24-15; 8:45 am]
 BILLING CODE 4184-01-P