Submission for OMB Review; Comment Request, 17419-17420 [2018-08233]

Download as PDF 17419 Federal Register / Vol. 83, No. 76 / Thursday, April 19, 2018 / Notices secure means of their choice (e.g., webbased application, fax or email). As part of this revision, CDC requests approval for a number of changes and adjustments: • CDC is discontinuing all Ebola related forms; • CDC is discontinuing all current maritime-related forms except a condensed maritime TB contact outbreak contact investigation follow up forms; • no changes are requested of the Air or Land associated forms; however adjustments in burden are requested. The proposed changes will result in a decrease of 673 burden hours (from 782 burden hours to 109 hours). There is no cost to respondents other than their time to complete the form and submit the data to CDC. investigation follow-up form in an Excel format; • CDC is requesting a downward revision of the estimated number of TB contact investigation forms used annually, but an upward revision of the amount of time requested from each respondent; • CDC is requesting addition of varicella and influenza like illness ESTIMATED ANNUALIZED BURDEN HOURS Form name Cruise Ship Physicians/Cargo Ship Managers Clinically Active TB Contact Investigation Outcome Reporting Form—Maritime. Varicella Investigation Outcome Reporting Form. Influenza Like Illness Investigation Outcome Reporting Form. General Contact Investigation Outcome Reporting Form—Air. TB Contact Investigation Outcome Reporting Form—Air. Measles Contact Investigation Outcome Reporting Form—Air. Rubella Contact Investigation Outcome Reporting Form—Air. General Contact Investigation Outcome Reporting Form—Land. Cruise Ship Physicians/Cargo Ship Managers Cruise Ship Physicians/Cargo Ship Managers State/Local public health staff ......................... State/Local public health staff ......................... State/Local public health staff ......................... State/Local public health staff ......................... State/Local public health staff ......................... 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. 2018–08163 Filed 4–18–18; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Submission for OMB Review; Comment Request Title: TANF Office Culture Study. OMB No.: New Collection. Description: The Administration for Children and Families (ACF), U.S. Number of responses per respondent Number of respondents Type of respondents Department of Health and Human Services (HHS) is proposing data collection activities as part of a project to identify and describe exemplars of TANF organizational culture as well as successful strategies human services offices have undertaken to improve their organizational culture. This qualitative study intends to use this information to increase understanding of how various agencies’ organizational cultures influence TANF clients’ experiences, service delivery, and frontline workers. The information collection activities to be submitted in the package include: (1) Leadership and supervisor interviews will collect information on program structure and staffing, client experiences, agency goals and performance management, organizational learning and innovation, cultural congruence across service Average burden per response (in hours) 15 1 20/60 29 1 20/60 45 1 20/60 34 1 5/60 547 1 5/60 324 1 5/60 27 1 5/60 15 1 5/60 providers, and the perception of the organizational culture change, if applicable. (2) Frontline workers’ interviews will collect information about frontline staffs’ role in service delivery, client experiences, peer interaction and social institutions within the agency, agency goals, organizational learning and innovation, and the perception of the organizational culture change initiative, if applicable. (3) The focus groups will collect information about program participants’ perceptions of agency processes, their communication with agency staff, and their assessment of the agency’s organizational culture. Respondents: Individuals receiving TANF and related services, TANF directors, and managers and staff at local TANF offices. daltland on DSKBBV9HB2PROD with NOTICES ANNUAL BURDEN ESTIMATES Total number of respondents Instrument Leadership and Supervisor Interview Guide ....................... Frontline Staff Interview Guide ............................................ Focus Group Guide ............................................................. VerDate Sep<11>2014 17:49 Apr 18, 2018 Jkt 244001 PO 00000 Frm 00061 Annual number of respondents 24 12 54 Fmt 4703 Sfmt 4703 Number of responses per respondent 8 4 18 E:\FR\FM\19APN1.SGM 1 1 1 19APN1 Average burden hours per response 1.5 1 1.5 Annual burden hours 12 4 27 17420 Federal Register / Vol. 83, No. 76 / Thursday, April 19, 2018 / Notices Estimated Total Annual Burden Hours: 43. 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, 330 C Street SW, Washington, DC 20201, Attn: OPRE Reports Clearance Officer. All requests should be identified by the title of the information collection. Email address: OPREinfocollection@ 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. Mary B. Jones, ACF/OPRE Certifying Officer. [FR Doc. 2018–08233 Filed 4–18–18; 8:45 am] BILLING CODE 4184–09–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–D–1098] Metered Dose Inhaler and Dry Powder Inhaler Drug Products—Quality Considerations; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ‘‘Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products—Quality Considerations.’’ The purpose of this guidance is to provide recommendations to industry on the development and manufacture of inhalation aerosols (also known as metered dose inhalers, or MDIs) and inhalation powders (also known as dry powder inhalers, or DPIs). Although not explicitly discussed, some of the principles and recommendations provided in this guidance may be applicable to nasal delivery products, as daltland on DSKBBV9HB2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:49 Apr 18, 2018 Jkt 244001 well. The recommendations in this guidance can apply to MDI and DPI products intended for local or systemic effect. DATES: Submit either electronic or written comments on the draft guidance by June 18, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// 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 https://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): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, 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 No. FDA– 2018–D–1098 for ‘‘Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products—Quality Considerations.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 https://www.regulations.gov. Submit both copies to the Dockets Management Staff. 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: https://www.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// 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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave. Hillandale Building, 4th Floor, Silver Spring, MD 20993– 0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Richard Lostritto, Center for Drug E:\FR\FM\19APN1.SGM 19APN1

Agencies

[Federal Register Volume 83, Number 76 (Thursday, April 19, 2018)]
[Notices]
[Pages 17419-17420]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-08233]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Administration for Children and Families


Submission for OMB Review; Comment Request

    Title: TANF Office Culture Study.
    OMB No.: New Collection.
    Description: The Administration for Children and Families (ACF), 
U.S. Department of Health and Human Services (HHS) is proposing data 
collection activities as part of a project to identify and describe 
exemplars of TANF organizational culture as well as successful 
strategies human services offices have undertaken to improve their 
organizational culture. This qualitative study intends to use this 
information to increase understanding of how various agencies' 
organizational cultures influence TANF clients' experiences, service 
delivery, and frontline workers.
    The information collection activities to be submitted in the 
package include:
    (1) Leadership and supervisor interviews will collect information 
on program structure and staffing, client experiences, agency goals and 
performance management, organizational learning and innovation, 
cultural congruence across service providers, and the perception of the 
organizational culture change, if applicable.
    (2) Frontline workers' interviews will collect information about 
frontline staffs' role in service delivery, client experiences, peer 
interaction and social institutions within the agency, agency goals, 
organizational learning and innovation, and the perception of the 
organizational culture change initiative, if applicable.
    (3) The focus groups will collect information about program 
participants' perceptions of agency processes, their communication with 
agency staff, and their assessment of the agency's organizational 
culture.
    Respondents: Individuals receiving TANF and related services, TANF 
directors, and managers and staff at local TANF offices.

                                             Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
           Instrument              Total number    Annual number   responses per     hours per     Annual burden
                                  of respondents  of respondents    respondent       response          hours
----------------------------------------------------------------------------------------------------------------
Leadership and Supervisor                     24               8               1             1.5              12
 Interview Guide................
Frontline Staff Interview Guide.              12               4               1               1               4
Focus Group Guide...............              54              18               1             1.5              27
----------------------------------------------------------------------------------------------------------------


[[Page 17420]]

    Estimated Total Annual Burden Hours: 43.
    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, 330 C Street SW, 
Washington, DC 20201, Attn: OPRE 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, Email: 
[email protected], Attn: Desk Officer for the Administration 
for Children and Families.

Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2018-08233 Filed 4-18-18; 8:45 am]
BILLING CODE 4184-09-P