Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for Quick Turnaround Testing of Communication Effectiveness, 35392-35393 [2019-15623]

Download as PDF 35392 Federal Register / Vol. 84, No. 141 / Tuesday, July 23, 2019 / Notices emailed or written, should be identified by the title of the information collection. SUPPLEMENTARY INFORMATION: Title IV–E of the Social Security Act (the Act) was amended by Public Law 115–123, which included the Family First Prevention Services Act (FFPSA). The FFPSA authorized new optional title IV–E funding for time-limited (one year) prevention services for mental health/ substance abuse and in-home parent skill-based programs for: (1) A child who is a candidate for foster care (as defined in section 475(13) of the Act), (2) pregnant/parenting foster youth, and (3) the parents/kin caregivers of those children and youth (sections 471(e), 474(a)(6), and 475(13) of the Act). Title IV–E prevention services must be rated as promising, supported, or wellsupported in accordance with HHS criteria and be approved by HHS (section 471(e)(4)(C) of the Act) as part of the Title IV–E Prevention Services Clearinghouse (section 476(d)(2) of the Act). A state or tribal title IV–E agency electing to participate in the program must submit a five-year title IV–E prevention program plan that meets the statutory requirements. (See Program Instructions ACYF–CB–PI–18–09 and ACYF–CB–PI–18–10 for more information.) The FFPSA also amended Section 474(a)(7) of the Act to reimburse state and tribal IV–E agencies for a portion of the costs of operating kinship navigator programs that meet certain criteria. To qualify for funding under the title IV– E Kinship Navigator program, the program must meet the requirements of a kinship navigator program described in section 427(a)(1) of the Act. The kinship navigator program must also meet practice criteria of promising, supported, or well-supported in accordance with HHS criteria and be approved by HHS (section 471(e)(4)(C) of the Act). To begin participation in the title IV–E Kinship Navigator Program, a title IV–E agency must submit an attachment to its title IV–E plan that specifies the Kinship Navigator model it has chosen to implement, the date on which the provision of program services began or will begin, and that provides an assurance that the model meets the requirements of section 427(a)(1) of the Act as well as a brief narrative describing how the program will be operated. (Please see Program Instruction ACYF–CB–PI–18–11 for additional information.) Respondents: State and tribal title IV– E agencies. ANNUAL BURDEN ESTIMATES Total number of respondents Instrument Title IV–E prevention services plan ................................................................. Attachment to Title IV–E plan for Kinship navigator program ......................... Estimated Total Annual Burden Hours: 195. Comments: The Department specifically requests comments on (a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication. Authority: Title IV–E of the Social Security Act as amended by Public Law (Pub. L.) 115–123 enacted February 9, 2018. jspears on DSK30JT082PROD with NOTICES Mary B. Jones, ACF/OPRE Certifying Officer. [FR Doc. 2019–15603 Filed 7–22–19; 8:45 am] BILLING CODE 4184–25–P VerDate Sep<11>2014 16:43 Jul 22, 2019 Jkt 247001 30 45 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–N–0430] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for Quick Turnaround Testing of Communication Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. Fax written comments on the collection of information by August 22, 2019. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202–395–7285, or emailed to DATES: Frm 00024 Fmt 4703 1 1 Average burden hours per response Annual burden hours 5 1 150 45 oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910-New and title ‘‘Generic Clearance for Quick Turnaround Testing of Communication Effectiveness.’’ Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–7726, PRAStaff@ fda.hhs.gov. In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (PRA). SUMMARY: PO 00000 Number of responses per respondent Sfmt 4703 Generic Clearance for Quick Turnaround Testing of Communication Effectiveness OMB Control Number 0910–NEW This notice announces the FDA information collection request to OMB for approval of a generic clearance that will allow FDA to use quick turnaround surveys, focus groups, and in-depth interviews collected from consumers and other stakeholders to communicate FDA issues of immediate and important public health significance. For example, E:\FR\FM\23JYN1.SGM 23JYN1 35393 Federal Register / Vol. 84, No. 141 / Tuesday, July 23, 2019 / Notices these methods of communication might be used when there is a foodborne illness outbreak, food recall, or other situation requiring expedited FDA food, dietary supplement, cosmetics, or animal food or feed communications. So that FDA may better protect the public health, the Agency needs quick turnaround information to help ensure its messaging has reached the target audience, has been effective, and, if needed, to update its communications during these events. FDA will only submit individual collections for approval under this generic clearance if they meet the following conditions: • The collections are voluntary; • The collections are low burden for participants (based on considerations of total burden hours, total number of participants, or burden hours per participant) and are low cost for both the participants and the Federal Government; • The collections are noncontroversial; • Personally identifiable information (PII) is collected only to the extent necessary 1 and is not retained; • Information gathered will not be used for the purpose of substantially informing influential policy decisions; 2 and • Information gathered will yield qualitative findings; the collections will not be designed or used as though the results are generalizable to the population of study. If these conditions are not met, FDA will submit an information collection request to OMB for approval through the normal PRA process. To obtain approval for an individual collection that meets the conditions of this generic clearance, an abbreviated supporting statement will be submitted to OMB along with supporting documentation (e.g., a copy of the survey, focus group moderator guide, or in-depth interviewing guide). Individual collections will also undergo review by FDA senior leadership in the Center for Food Safety and Applied Nutrition, PRA specialists, and an institutional review board. Respondents to this collection of information include a wide range of consumers and other FDA stakeholders such as producers and manufacturers who are regulated under FDA-regulated food and cosmetic products, dietary supplements, and animal food and feed. In the Federal Register of April 2, 2019 (84 FR 12617), FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received no comments. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents Survey type Total annual responses Average burden hours per response Total hours In-depth Interviews, Cognitive Interviews Screener In-depth Interviews, Cognitive Interviews ................ In-depth Interviews Screener ................................... In-depth Interviews ................................................... Survey Cognitive Interviews Screener ..................... Survey Cognitive Interviews .................................... Pretest survey screener ........................................... Pretest survey .......................................................... Self-Administered Surveys—Study Screener .......... Self-Administered Surveys ....................................... Focus Group/Small Group, Cognitive Groups Screener. Focus Group/Small Group, Cognitive Groups ......... Focus Group/Small Group Participant Screening ... Focus Group/Small Group Discussion .................... 45 9 900 180 45 9 750 150 75,000 15,000 180 1 1 1 1 1 1 1 1 1 1 1 45 9 900 180 45 9 750 150 75,000 15,000 180 0.083 (5 minutes) ...... 1 ................................ 0.083 (5 minutes) ...... 1 ................................ 0.083 (5 minutes) ...... 1 ................................ 0.083 (5 minutes) ...... 0.25 (15 minutes) ...... 0.083 (5 minutes) ...... 0.25 (15 minutes) ...... 0.083 (5 minutes) ...... 4 9 75 180 4 9 62.25 38 6,225 3,750 15 60 720 240 1 1 1 60 720 240 1.5 (90 minutes) ........ 0.083 (5 minutes) ...... 1.5 (90 minutes) ........ 90 60 360 Total .................................................................. ........................ ........................ ........................ .................................... 10,881.25 1 There are no capital costs or operating and maintenance costs associated with this collection of information. This is a new collection of information whose total estimated annual burden is 10,881.25 hours. Current estimates are based on both historical numbers of participants from past projects as well as estimates for projects to be conducted in the next 3 years. The number of participants to be included in each new individual survey will vary, depending on the nature of the compliance efforts and the target audience. jspears on DSK30JT082PROD with NOTICES Number of responses per respondent Dated: July 16, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–15623 Filed 7–22–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0065] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Registration of Food Facilities AGENCY: Food and Drug Administration, HHS. 1 For example, collections that collect PII to provide remuneration for participants of focus groups, in-depth interviews, and cognitive laboratory studies will be submitted under this request. All privacy act requirements will be met. VerDate Sep<11>2014 16:43 Jul 22, 2019 Jkt 247001 2 As defined in OMB and Agency Information Quality Guidelines, ‘‘influential’’ means that ‘‘an agency can reasonably determine that dissemination of the information will have or does have a clear and substantial impact on important PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 public policies or important private sector decisions.’’ E:\FR\FM\23JYN1.SGM 23JYN1

Agencies

[Federal Register Volume 84, Number 141 (Tuesday, July 23, 2019)]
[Notices]
[Pages 35392-35393]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15623]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-0430]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Generic Clearance for 
Quick Turnaround Testing of Communication Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995 (PRA).

DATES: Fax written comments on the collection of information by August 
22, 2019.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-New and 
title ``Generic Clearance for Quick Turnaround Testing of Communication 
Effectiveness.'' Also include the FDA docket number found in brackets 
in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Generic Clearance for Quick Turnaround Testing of Communication 
Effectiveness

OMB Control Number 0910-NEW

    This notice announces the FDA information collection request to OMB 
for approval of a generic clearance that will allow FDA to use quick 
turnaround surveys, focus groups, and in-depth interviews collected 
from consumers and other stakeholders to communicate FDA issues of 
immediate and important public health significance. For example,

[[Page 35393]]

these methods of communication might be used when there is a foodborne 
illness outbreak, food recall, or other situation requiring expedited 
FDA food, dietary supplement, cosmetics, or animal food or feed 
communications. So that FDA may better protect the public health, the 
Agency needs quick turnaround information to help ensure its messaging 
has reached the target audience, has been effective, and, if needed, to 
update its communications during these events.
    FDA will only submit individual collections for approval under this 
generic clearance if they meet the following conditions:
     The collections are voluntary;
     The collections are low burden for participants (based on 
considerations of total burden hours, total number of participants, or 
burden hours per participant) and are low cost for both the 
participants and the Federal Government;
     The collections are noncontroversial;
     Personally identifiable information (PII) is collected 
only to the extent necessary \1\ and is not retained;
---------------------------------------------------------------------------

    \1\ For example, collections that collect PII to provide 
remuneration for participants of focus groups, in-depth interviews, 
and cognitive laboratory studies will be submitted under this 
request. All privacy act requirements will be met.
---------------------------------------------------------------------------

     Information gathered will not be used for the purpose of 
substantially informing influential policy decisions; \2\ and
---------------------------------------------------------------------------

    \2\ As defined in OMB and Agency Information Quality Guidelines, 
``influential'' means that ``an agency can reasonably determine that 
dissemination of the information will have or does have a clear and 
substantial impact on important public policies or important private 
sector decisions.''
---------------------------------------------------------------------------

     Information gathered will yield qualitative findings; the 
collections will not be designed or used as though the results are 
generalizable to the population of study.
    If these conditions are not met, FDA will submit an information 
collection request to OMB for approval through the normal PRA process.
    To obtain approval for an individual collection that meets the 
conditions of this generic clearance, an abbreviated supporting 
statement will be submitted to OMB along with supporting documentation 
(e.g., a copy of the survey, focus group moderator guide, or in-depth 
interviewing guide).
    Individual collections will also undergo review by FDA senior 
leadership in the Center for Food Safety and Applied Nutrition, PRA 
specialists, and an institutional review board.
    Respondents to this collection of information include a wide range 
of consumers and other FDA stakeholders such as producers and 
manufacturers who are regulated under FDA-regulated food and cosmetic 
products, dietary supplements, and animal food and feed.
    In the Federal Register of April 2, 2019 (84 FR 12617), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received no comments.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
                 Survey type                     Number of     responses per   Total annual        Average burden hours per response        Total hours
                                                respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
In-depth Interviews, Cognitive Interviews                 45               1              45  0.083 (5 minutes).........................               4
 Screener.
In-depth Interviews, Cognitive Interviews...               9               1               9  1.........................................               9
In-depth Interviews Screener................             900               1             900  0.083 (5 minutes).........................              75
In-depth Interviews.........................             180               1             180  1.........................................             180
Survey Cognitive Interviews Screener........              45               1              45  0.083 (5 minutes).........................               4
Survey Cognitive Interviews.................               9               1               9  1.........................................               9
Pretest survey screener.....................             750               1             750  0.083 (5 minutes).........................           62.25
Pretest survey..............................             150               1             150  0.25 (15 minutes).........................              38
Self-Administered Surveys--Study Screener...          75,000               1          75,000  0.083 (5 minutes).........................           6,225
Self-Administered Surveys...................          15,000               1          15,000  0.25 (15 minutes).........................           3,750
Focus Group/Small Group, Cognitive Groups                180               1             180  0.083 (5 minutes).........................              15
 Screener.
Focus Group/Small Group, Cognitive Groups...              60               1              60  1.5 (90 minutes)..........................              90
Focus Group/Small Group Participant                      720               1             720  0.083 (5 minutes).........................              60
 Screening.
Focus Group/Small Group Discussion..........             240               1             240  1.5 (90 minutes)..........................             360
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..............  ..........................................       10,881.25
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    This is a new collection of information whose total estimated 
annual burden is 10,881.25 hours. Current estimates are based on both 
historical numbers of participants from past projects as well as 
estimates for projects to be conducted in the next 3 years. The number 
of participants to be included in each new individual survey will vary, 
depending on the nature of the compliance efforts and the target 
audience.

    Dated: July 16, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-15623 Filed 7-22-19; 8:45 am]
BILLING CODE 4164-01-P


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