Agency Forms Undergoing Paperwork Reduction Act Review, 5760-5761 [2015-02062]

Download as PDF 5760 Federal Register / Vol. 80, No. 22 / Tuesday, February 3, 2015 / Notices SUPPLEMENTARY INFORMATION: Pursuant to the Federal Advisory Committee Act (FACA) of 1972 (5 U.S. C., Appendix, as amended), and section 2811A of the Public Health Service (PHS) Act (42 U.S. C. 300hh–10a), as added by section 103 of the Pandemic and All Hazards Preparedness Reauthorization Act of 2013 (Pub. L. 113–5), the HHS Secretary, in consultation with the Secretary of the U.S. Department of Homeland Security, established the National Advisory Committee on Children and Disasters (NACCD). The purpose of the NACCD is to provide advice and consultation to the HHS Secretary with respect to the medical and public health needs of children in relation to disasters. The Office of the Assistant Secretary for Preparedness and Response (ASPR) provides management and administrative oversight to support the activities of the NACCD. Background: This public meeting will be dedicated to the members voting to approve the report of findings of the NACCD Surge Capacity Work Group. Availability of Materials: The meeting agenda and materials will be posted on the NACCD Web site at: www.phe.gov/ naccd prior to the meeting. Procedures for Providing Public Input: All written comments must be received prior to February 24, 2015. Please submit comments via the NACCD Contact Form located at www.phe.gov/ NACCDComments. Individuals who plan to attend and need special assistance should submit a request via the NACCD Contact Form located at www.phe.gov/NACCDComments. published to obtain comments from the public and affected agencies. Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address any of the following: (a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) Enhance the quality, utility, and clarity of the information to be collected; (d) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses; and (e) Assess information collection costs. To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639–7570 or send an email to omb@cdc.gov. Written comments and/or suggestions regarding the items contained in this notice should be directed to the Attention: CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to (202) 395–5806. Written comments should be received within 30 days of this notice. Dated: January 22, 2015. Nicole Lurie, Assistant Secretary for Preparedness and Response. Proposed Project [FR Doc. 2015–01615 Filed 2–2–15; 8:45 am] BILLING CODE P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day–15–0940] rljohnson on DSK3VPTVN1PROD with NOTICES Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention (CDC) has submitted the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The notice for the proposed information collection is VerDate Sep<11>2014 14:46 Feb 02, 2015 Jkt 235001 Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery (OMB No. 0920–0940, exp. 06/30/2015)—Extension—Centers for Disease Control and Prevention (CDC), National Institute for Occupational Safety and Health (NIOSH), Health Hazard Evaluation Program. As part of a Federal Government-wide effort to streamline the process to seek feedback from the public on service delivery, the CDC has submitted a Generic Information Collection Request (Generic ICR): ‘‘Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery ’’ to OMB for approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et. seq.). To request additional information, please contact Leroy A. Richardson, Centers for Disease Control and Prevention, 1600 Clifton Road, MS–D74, PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 Atlanta, GA 30333 or send an email to omb@cdc.gov. SUPPLEMENTARY INFORMATION: Title: Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery. Abstract: The information collection activity will garner qualitative customer and stakeholder feedback in an efficient, timely manner, in accordance with the Administration’s commitment to improving service delivery. By qualitative feedback we mean information that provides useful insights on perceptions and opinions, but are not statistical surveys that yield quantitative results that can be generalized to the population of study. This feedback will provide insights into customer or stakeholder perceptions, experiences and expectations, provide an early warning of issues with service, or focus attention on areas where communication, training or changes in operations might improve delivery of products or services. These collections will allow for ongoing, collaborative and actionable communications between the Agency and its customers and stakeholders. It will also allow feedback to contribute directly to the improvement of program management. Feedback collected under this generic clearance will provide useful information, but it will not yield data that can be generalized to the overall population. This type of generic clearance for qualitative information will not be used for quantitative information collections that are designed to yield reliably actionable results, such as monitoring trends over time or documenting program performance. Such data uses require more rigorous designs that address: The target population to which generalizations will be made, the sampling frame, the sample design (including stratification and clustering), the precision requirements or power calculations that justify the proposed sample size, the expected response rate, methods for assessing potential nonresponse bias, the protocols for data collection, and any testing procedures that were or will be undertaken prior fielding the study. Depending on the degree of influence the results are likely to have, such collections may still be eligible for submission for other generic mechanisms that are designed to yield quantitative results. The Agency received no comments in response to the 60-day notice published in the Federal Register on April 30, 2014 (75 FR 24432). This is a new collection of information. Respondents will be E:\FR\FM\03FEN1.SGM 03FEN1 5761 Federal Register / Vol. 80, No. 22 / Tuesday, February 3, 2015 / Notices screened and selected from Individuals and Households, Businesses, Organizations, and/or State, Local or Tribal Government. There is no cost to respondents other than their time. The estimated total burden hours for this data collection activity are 268. Type of collection Average number of respondents per activity Annual frequency per response Average number of activities Average hours per response Online surveys, Telephone Surveys, Focus Groups, In person observation/ testing ........................................................................................................... 67 1 5 48/60 Leroy A. Richardson, Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention. DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2015–02062 Filed 2–2–15; 8:45 am] Agency Information Collection Activities; Proposed Collection; Comment Request; General Licensing Provisions; Section 351(k) Biosimilar Applications BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES ACTION: rljohnson on DSK3VPTVN1PROD with NOTICES Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. 14:46 Feb 02, 2015 Jkt 235001 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 information collection in an application for a proposed biosimilar product and an application for a supplement for a proposed interchangeable product. DATES: Submit either electronic or written comments on the collection of information by April 6, 2015. ADDRESSES: Submit electronic comments on the collection of information to https:// 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. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. SUMMARY: This gives notice under the Federal Advisory Committee Act (Pub. L. 92– 463) of October 6, 1972, that the Board of Scientific Counselors, National Center for Environmental Health/ Agency for Toxic Substances and Disease Registry, Department of Health and Human Services, has been renewed for a 2-year period through May 21, 2016. For information, contact William Cibulas, Ph.D., Designated Federal Officer, Board of Scientific Counselors, National Center for Environmental Health/Agency for Toxic Substances and Disease Registry, Department of Health and Human Services, 4770 Buford Highway, Mailstop F61, Chamblee, Georgia 30341, telephone (770) 488–0662 or fax (770) 488–3385. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. VerDate Sep<11>2014 Food and Drug Administration, HHS. Board of Scientific Counselors, National Center for Environmental Health/Agency for Toxic Substances and Disease Registry: Notice of Charter Renewal BILLING CODE 4163–18–P [Docket No. FDA–2012–N–0129] AGENCY: Centers for Disease Control and Prevention [FR Doc. 2015–02026 Filed 2–2–15; 8:45 am] Food and Drug Administration PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 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 these topics: (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: General Licensing Provisions; Section 351(k) Biosimilar Applications (OMB Control Number 0910–0719)—Extension The Patient Protection and Affordable Care Act (Affordable Care Act) (Pub. L. 111–148) contains a subtitle called the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), which amends the Public Health Service Act (PHS Act) and establishes an abbreviated licensure pathway for E:\FR\FM\03FEN1.SGM 03FEN1

Agencies

[Federal Register Volume 80, Number 22 (Tuesday, February 3, 2015)]
[Notices]
[Pages 5760-5761]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-02062]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-15-0940]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) has submitted 
the following information collection request to the Office of 
Management and Budget (OMB) for review and approval in accordance with 
the Paperwork Reduction Act of 1995. The notice for the proposed 
information collection is published to obtain comments from the public 
and affected agencies.
    Written comments and suggestions from the public and affected 
agencies concerning the proposed collection of information are 
encouraged. Your comments should address any of the following: (a) 
Evaluate whether the proposed collection of information is necessary 
for the proper performance of the functions of the agency, including 
whether the information will have practical utility; (b) Evaluate the 
accuracy of the agencies estimate of the burden of the proposed 
collection of information, including the validity of the methodology 
and assumptions used; (c) Enhance the quality, utility, and clarity of 
the information to be collected; (d) Minimize the burden of the 
collection of information on those who are to respond, including 
through the use of appropriate automated, electronic, mechanical, or 
other technological collection techniques or other forms of information 
technology, e.g., permitting electronic submission of responses; and 
(e) Assess information collection costs.
    To request additional information on the proposed project or to 
obtain a copy of the information collection plan and instruments, call 
(404) 639-7570 or send an email to omb@cdc.gov. Written comments and/or 
suggestions regarding the items contained in this notice should be 
directed to the Attention: CDC Desk Officer, Office of Management and 
Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written 
comments should be received within 30 days of this notice.

Proposed Project

    Generic Clearance for the Collection of Qualitative Feedback on 
Agency Service Delivery (OMB No. 0920-0940, exp. 06/30/2015)--
Extension--Centers for Disease Control and Prevention (CDC), National 
Institute for Occupational Safety and Health (NIOSH), Health Hazard 
Evaluation Program.
    As part of a Federal Government-wide effort to streamline the 
process to seek feedback from the public on service delivery, the CDC 
has submitted a Generic Information Collection Request (Generic ICR): 
``Generic Clearance for the Collection of Qualitative Feedback on 
Agency Service Delivery '' to OMB for approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et. seq.).
    To request additional information, please contact Leroy A. 
Richardson, Centers for Disease Control and Prevention, 1600 Clifton 
Road, MS-D74, Atlanta, GA 30333 or send an email to omb@cdc.gov.

SUPPLEMENTARY INFORMATION:
    Title: Generic Clearance for the Collection of Qualitative Feedback 
on Agency Service Delivery.
    Abstract: The information collection activity will garner 
qualitative customer and stakeholder feedback in an efficient, timely 
manner, in accordance with the Administration's commitment to improving 
service delivery. By qualitative feedback we mean information that 
provides useful insights on perceptions and opinions, but are not 
statistical surveys that yield quantitative results that can be 
generalized to the population of study. This feedback will provide 
insights into customer or stakeholder perceptions, experiences and 
expectations, provide an early warning of issues with service, or focus 
attention on areas where communication, training or changes in 
operations might improve delivery of products or services. These 
collections will allow for ongoing, collaborative and actionable 
communications between the Agency and its customers and stakeholders. 
It will also allow feedback to contribute directly to the improvement 
of program management.
    Feedback collected under this generic clearance will provide useful 
information, but it will not yield data that can be generalized to the 
overall population. This type of generic clearance for qualitative 
information will not be used for quantitative information collections 
that are designed to yield reliably actionable results, such as 
monitoring trends over time or documenting program performance. Such 
data uses require more rigorous designs that address: The target 
population to which generalizations will be made, the sampling frame, 
the sample design (including stratification and clustering), the 
precision requirements or power calculations that justify the proposed 
sample size, the expected response rate, methods for assessing 
potential non-response bias, the protocols for data collection, and any 
testing procedures that were or will be undertaken prior fielding the 
study. Depending on the degree of influence the results are likely to 
have, such collections may still be eligible for submission for other 
generic mechanisms that are designed to yield quantitative results.
    The Agency received no comments in response to the 60-day notice 
published in the Federal Register on April 30, 2014 (75 FR 24432).
    This is a new collection of information. Respondents will be

[[Page 5761]]

screened and selected from Individuals and Households, Businesses, 
Organizations, and/or State, Local or Tribal Government. There is no 
cost to respondents other than their time. The estimated total burden 
hours for this data collection activity are 268.

----------------------------------------------------------------------------------------------------------------
                                               Average number       Annual
             Type of collection               of  respondents   frequency per    Average number   Average hours
                                                per activity       response      of activities     per response
----------------------------------------------------------------------------------------------------------------
Online surveys, Telephone Surveys, Focus                  67                1                5            48/60
 Groups, In person observation/testing......
----------------------------------------------------------------------------------------------------------------


Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific 
Integrity, Office of the Associate Director for Science, Office of the 
Director, Centers for Disease Control and Prevention.
[FR Doc. 2015-02062 Filed 2-2-15; 8:45 am]
BILLING CODE 4163-18-P
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