Submission for OMB Review; Family Level Assessment and State of Home Visiting (FLASH-V) Outreach and Recruitment Study (New Collection), 59318-59319 [2020-20733]

Download as PDF 59318 Federal Register / Vol. 85, No. 183 / Monday, September 21, 2020 / Notices information will be on public display. CDC will review all submissions and may choose to redact, or withhold, submissions containing private or proprietary information such as Social Security numbers, medical information, inappropriate language, or duplicate/ near duplicate examples of a mass-mail campaign. CDC will carefully consider all comments submitted into the docket. CDC does not accept comment by email. Oral Public Comment: This meeting will include time for members of the public to make an oral comment. Oral public comment will occur before any scheduled votes including all votes relevant to the ACIP’s Affordable Care Act and Vaccines for Children Program roles. Priority will be given to individuals who submit a request to make an oral public comment before the meeting according to the procedures below. 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Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/ PRAMain. Find this particular information collection by selecting ‘‘Currently under 30-day Review—Open for Public Comments’’ or by using the search function. ADDRESSES: SUPPLEMENTARY INFORMATION: Administration for Children and Families Submission for OMB Review; Family Level Assessment and State of Home Visiting (FLASH–V) Outreach and Recruitment Study (New Collection) Office of Planning, Research, and Evaluation, Administration for Children and Families, HHS. ACTION: Request for public comment. AGENCY: The Administration for Children and Families (ACF) Office of Planning, Research, and Evaluation is requesting public comment on new data collection activities to gather information about how Maternal, Infant, and Early Childhood Home Visiting (MIECHV) state and territory local implementing agencies (LIAs) and tribal grantees recruit families for program participation and work with their community referral partners to recruit families. The project is designed to examine challenges programs experience reaching caseload capacity and promising strategies to address how challenges might be overcome. DATES: Comments due within 30 days of publication. OMB must make a decision about the collection of information SUMMARY: Description: The ACF Office of Planning, Research, and Evaluation is proposing a new information collection to learn more about how MIECHVfunded home visiting programs recruit families for home visiting services. The voluntary study will include a national survey of MIECHV-funded program managers, semi-structured interviews with program staff, and a review of program outreach and recruitment materials. This descriptive work will capture how programs identify and recruit families to home visiting services. The study will also capture how outreach and recruitment challenges and accomplishments related to capacity have changed since COVID– 19 and identify strategies programs have used to address associated challenges. The activities and products from this project will help ACF and the Health Resources and Services Administration to identify actionable bottlenecks in the outreach and recruitment process to allow for the development and testing of strategies to improve the delivery of MIECHV funded services. Respondents: MIECHV funded state, territory, or tribal grantee administrators; program administrators; program managers; and frontline staff. ANNUAL BURDEN ESTIMATES Instrument Total number of respondents Number of responses per respondent 56 779 120 1 1 1 jbell on DSKJLSW7X2PROD with NOTICES Request for LIA Contact Information from MIECHV Leads LIA Survey ........................................................................... Interview Protocol Local Implementing Agency ................... VerDate Sep<11>2014 19:59 Sep 18, 2020 Jkt 250001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 Average burden hours per response E:\FR\FM\21SEN1.SGM .25 .50 .75 21SEN1 Total burden hours 14 390 90 Annual burden hours 7 195 45 Federal Register / Vol. 85, No. 183 / Monday, September 21, 2020 / Notices Estimated Total Annual Burden Hours: 247 hours. Authority: Social Security Act Title V § 511 [42 U.S.C. 711]. As extended by the Bipartisan Budget Act of 2018 (Pub. L. 115– 123) through FY 22. John M. Sweet Jr., ACF/OPRE Certifying Officer. [FR Doc. 2020–20733 Filed 9–18–20; 8:45 am] BILLING CODE 4182–74–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2020–D–1825] Investigational COVID–19 Convalescent Plasma; Guidance for Industry; Availability Food and Drug Administration, Health and Human Services (HHS). ACTION: Notice of availability. AGENCY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ‘‘Investigational COVID–19 Convalescent Plasma.’’ The guidance document provides recommendations to healthcare providers and investigators on the use of investigational convalescent plasma for the treatment of the Coronavirus Disease 2019 (COVID–19) during the public health emergency. The guidance announced in this notice supersedes the guidance of the same title dated April 2020 and updated in May 2020. The guidance includes a discussion to facilitate the availability of investigational convalescent plasma when blood establishments, hospitals, and healthcare providers collect plasma that does not meet the Conditions of Authorization of the Emergency Use Authorization (EUA). The guidance also provides recommendations for healthcare providers who wish to administer and study convalescent plasma under an investigational new drug (IND) application. DATES: The announcement of the guidance is published in the Federal Register on September 21, 2020. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows: jbell on DSKJLSW7X2PROD with NOTICES SUMMARY: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. VerDate Sep<11>2014 19:59 Sep 18, 2020 Jkt 250001 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– 2020–D–1825 for ‘‘Investigational COVID–19 Convalescent Plasma.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential 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, 240–402–7500. • 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 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 59319 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.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.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, 240–402–7500. 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 guidance to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist the office in processing your requests. The guidance may also be obtained by mail by calling CBER at 1– 800–835–4709 or 240–402–8010. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Shruti Modi, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240– 402–7911. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance entitled ‘‘Investigational COVID–19 Convalescent Plasma.’’ The guidance provides recommendations to healthcare providers and investigators on the use of investigational convalescent plasma for the treatment of COVID–19 during the public health E:\FR\FM\21SEN1.SGM 21SEN1

Agencies

[Federal Register Volume 85, Number 183 (Monday, September 21, 2020)]
[Notices]
[Pages 59318-59319]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-20733]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Administration for Children and Families


Submission for OMB Review; Family Level Assessment and State of 
Home Visiting (FLASH-V) Outreach and Recruitment Study (New Collection)

AGENCY: Office of Planning, Research, and Evaluation, Administration 
for Children and Families, HHS.

ACTION: Request for public comment.

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

SUMMARY: The Administration for Children and Families (ACF) Office of 
Planning, Research, and Evaluation is requesting public comment on new 
data collection activities to gather information about how Maternal, 
Infant, and Early Childhood Home Visiting (MIECHV) state and territory 
local implementing agencies (LIAs) and tribal grantees recruit families 
for program participation and work with their community referral 
partners to recruit families. The project is designed to examine 
challenges programs experience reaching caseload capacity and promising 
strategies to address how challenges might be overcome.

DATES: Comments due within 30 days of publication. OMB must make a 
decision about 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.

ADDRESSES: Written comments and recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular 
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.

SUPPLEMENTARY INFORMATION:
    Description: The ACF Office of Planning, Research, and Evaluation 
is proposing a new information collection to learn more about how 
MIECHV-funded home visiting programs recruit families for home visiting 
services. The voluntary study will include a national survey of MIECHV-
funded program managers, semi-structured interviews with program staff, 
and a review of program outreach and recruitment materials. This 
descriptive work will capture how programs identify and recruit 
families to home visiting services. The study will also capture how 
outreach and recruitment challenges and accomplishments related to 
capacity have changed since COVID-19 and identify strategies programs 
have used to address associated challenges. The activities and products 
from this project will help ACF and the Health Resources and Services 
Administration to identify actionable bottlenecks in the outreach and 
recruitment process to allow for the development and testing of 
strategies to improve the delivery of MIECHV funded services.
    Respondents: MIECHV funded state, territory, or tribal grantee 
administrators; program administrators; program managers; and frontline 
staff.

                                             Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
                                                     Number of        Average
           Instrument              Total number    responses per   burden hours    Total burden    Annual burden
                                  of respondents    respondent     per response        hours           hours
----------------------------------------------------------------------------------------------------------------
Request for LIA Contact                       56               1             .25              14               7
 Information from MIECHV Leads..
LIA Survey......................             779               1             .50             390             195
Interview Protocol Local                     120               1             .75              90              45
 Implementing Agency............
----------------------------------------------------------------------------------------------------------------


[[Page 59319]]

    Estimated Total Annual Burden Hours: 247 hours.

    Authority: Social Security Act Title V Sec.  511 [42 U.S.C. 
711]. As extended by the Bipartisan Budget Act of 2018 (Pub. L. 115-
123) through FY 22.

John M. Sweet Jr.,
ACF/OPRE Certifying Officer.
[FR Doc. 2020-20733 Filed 9-18-20; 8:45 am]
BILLING CODE 4182-74-P