83 FR 45630 - Proposed Information Collection Activity; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families Federal Register Volume 83, Issue 175 (September 10, 2018)
Administration for Children and Families
Federal Register Volume 83, Issue 175 (September 10, 2018)
| Page Range | 45630-45631 | |
| FR Document | 2018-19561 |
[Federal Register Volume 83, Number 175 (Monday, September 10, 2018)] [Notices] [Pages 45630-45631] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-19561] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Proposed Information Collection Activity; Comment Request Title: Tribal Maternal, Infant, and Early Childhood Home Visiting Program Quarterly Performance Reporting Form. OMB No.: New Collection. Description: The Administration for Children and Families (ACF), Office of Child Care, in collaboration with the Health Resources and Services Administration (HRSA), Maternal and Child Health Bureau, administers the Maternal, Infant, and Early Childhood Home Visiting (MIECHV) Program, as authorized by Title V, Section 511 of the Social Security Act. The Administration for Children and Families administers the Tribal MIECHV Program while HRSA administers the State/Territory MIECHV Program. Tribal MIECHV discretionary grants support cooperative agreements to conduct community needs assessments; plan for and implement high-quality, culturally-relevant, evidence-based home visiting programs in at-risk tribal communities; establish, measure, and report on progress toward meeting performance measures in six legislatively-mandated benchmark areas; and conduct rigorous evaluation activities to build the knowledge base on home visiting among Native populations. The proposed data collection form is as follows: In order to continuously monitor, provide grant oversight, quality improvement guidance, and technical assistance to Tribal MIECHV grantees, ACF is seeking to collect services utilization data on a quarterly basis. The Tribal MIECHV Quarterly Data Performance Reporting Form, is made up of five categories of data--program capacity, place-based services, family engagement, staff recruitment and retention and staff vacancies. This form will be used by Tribal MIECHV grantees that receive grants under the Tribal MIECHV Program to collect data in order to determine the caseload capacity grantees are achieving, where services are being delivered, the retention and attrition of enrolled families, and the retention and attrition of program staff on a quarterly basis. Respondents: Tribal Maternal, Infant, and Early Childhood Home Visiting Program Managers. The information collection does not include direct interaction with individuals or families that receive the services. Annual Burden Estimates ---------------------------------------------------------------------------------------------------------------- Number of Average burden Type of respondent Form name Number of responses per per response Total burden respondents respondent (in hours) hours ---------------------------------------------------------------------------------------------------------------- Tribal MIECHV Grantees........ Tribal MIECHV 25 4 24 2,400 Quarterly Reporting Form. --------------------------------------------------------------- Total..................... ................ .............. .............. .............. 2,400 ---------------------------------------------------------------------------------------------------------------- Estimated Total Annual Burden Hours: 2,400. In compliance with the requirements of the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. Chap 35), the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 330 C Street SW, Washington DC 20201. Attn: ACF Reports Clearance Officer. Email address: [email protected]. All requests should be identified by the title of the information collection. 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 [[Page 45631]] 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. Robert A. Sargis, Reports Clearance Officer. [FR Doc. 2018-19561 Filed 9-7-18; 8:45 am] BILLING CODE 4184-01-P
![45630 Federal Register / Vol. 83, No. 175 / Monday, September 10, 2018 / Notices
b One was from a commenter who to strengthen and improve the quality of for Children and Families administers
did not provide an affiliation. The the Systematic Review and Guideline. the Tribal MIECHV Program while
commenter shared concerns regarding The final Systematic Review and HRSA administers the State/Territory
how the level of evidence was graded. Guideline on the Diagnosis and MIECHV Program. Tribal MIECHV
b One was from a healthcare Management of Mild Traumatic Brain discretionary grants support cooperative
provider who shared citations for Injury Among Children can be found at agreements to conduct community
consideration. https://jamanetwork.com/journals/ needs assessments; plan for and
b One was from an advocacy group jamapediatrics/fullarticle/2698456? implement high-quality, culturally-
that provided a comment outside the guestAccessKey=80a9ecdc-ea57-447d- relevant, evidence-based home visiting
scope of the docket. a1b3-b4a87cadd40d (Guideline) and programs in at-risk tribal communities;
A summary of the revisions made to https://jamanetwork.com/journals/ establish, measure, and report on
the final Systematic Review and jamapediatrics/fullarticle/2698455? progress toward meeting performance
Guideline based on external peer guestAccessKey=24b78e3d-571f-49fb- measures in six legislatively-mandated
reviewer comments are posted in the 9daf-499d2b3e2cc1 (Systematic benchmark areas; and conduct rigorous
Supporting Documents section of the Review). evaluation activities to build the
docket (document titled ‘‘Ped mTBI Dated: September 5, 2018. knowledge base on home visiting among
Guideline Response to Peer Reviewer Lauren Hoffmann, Native populations.
Comments’’). Acting Executive Secretary, Centers for The proposed data collection form is
CDC also revised the document based Disease Control and Prevention. as follows: In order to continuously
on public comments. For example, a few [FR Doc. 2018–19536 Filed 9–7–18; 8:45 am] monitor, provide grant oversight, quality
commenters expressed concern BILLING CODE 4163–18–P
improvement guidance, and technical
regarding recommendations not being assistance to Tribal MIECHV grantees,
applicable in the emergency care ACF is seeking to collect services
setting. As the clinical DEPARTMENT OF HEALTH AND utilization data on a quarterly basis. The
recommendations in the guideline were HUMAN SERVICES Tribal MIECHV Quarterly Data
created for both the acute care and Performance Reporting Form, is made
primary care setting, CDC added Administration for Children and up of five categories of data—program
language to emphasize that the Families capacity, place-based services, family
recommendations were drafted to be engagement, staff recruitment and
relevant for both settings. As another Proposed Information Collection retention and staff vacancies. This form
example, multiple comments were Activity; Comment Request will be used by Tribal MIECHV grantees
received regarding the content in the Title: Tribal Maternal, Infant, and that receive grants under the Tribal
systematic review on the use of CT Early Childhood Home Visiting Program MIECHV Program to collect data in
imaging. Commenters explained that Quarterly Performance Reporting Form. order to determine the caseload capacity
current evidence that provides the basis OMB No.: New Collection. grantees are achieving, where services
for CT imaging focus on ruling out Description: The Administration for are being delivered, the retention and
clinically-important traumatic brain Children and Families (ACF), Office of attrition of enrolled families, and the
injury among pediatric patients Child Care, in collaboration with the retention and attrition of program staff
presenting with a TBI. In response, CDC Health Resources and Services on a quarterly basis.
revised the conclusion to specify that Administration (HRSA), Maternal and Respondents: Tribal Maternal, Infant,
the recommendations are for children Child Health Bureau, administers the and Early Childhood Home Visiting
presenting with mTBI versus TBI of all Maternal, Infant, and Early Childhood Program Managers. The information
severity levels in the acute care setting. Home Visiting (MIECHV) Program, as collection does not include direct
All public and peer reviewer comments authorized by Title V, Section 511 of the interaction with individuals or families
were carefully reviewed and considered Social Security Act. The Administration that receive the services.
ANNUAL BURDEN ESTIMATES
Average
Number of
Number of burden per Total
Type of respondent Form name responses per
respondents response burden hours
respondent (in hours)
Tribal MIECHV Grantees .................. Tribal MIECHV Quarterly Reporting 25 4 24 2,400
Form.
Total ........................................... ........................................................... ........................ ........................ ........................ 2,400
Estimated Total Annual Burden information can be obtained and The Department specifically requests
Hours: 2,400. comments may be forwarded by writing comments on: (a) Whether the proposed
In compliance with the requirements to the Administration for Children and collection of information is necessary
daltland on DSKBBV9HB2PROD with NOTICES
of the Paperwork Reduction Act of 1995 Families, Office of Planning, Research for the proper performance of the
(Pub. L. 104–13, 44 U.S.C. Chap 35), the and Evaluation, 330 C Street SW, functions of the agency, including
Administration for Children and Washington DC 20201. Attn: ACF whether the information shall have
Families is soliciting public comment Reports Clearance Officer. Email practical utility; (b) the accuracy of the
on the specific aspects of the address: infocollection@acf.hhs.gov. All agency’s estimate of the burden of the
information collection described above. requests should be identified by the title proposed collection of information; (c)
Copies of the proposed collection of of the information collection. the quality, utility, and clarity of the
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![Federal Register / Vol. 83, No. 175 / Monday, September 10, 2018 / Notices 45631
information to be collected; and (d) February 19, 2015 (80 FR 8874), as of Products Between the States and the
ways to minimize the burden of the September 10, 2018. Submit either Food and Drug Administration; Revised
collection of information on electronic or written comments on the Draft; Availability.’’ Received comments
respondents, including through the use revised draft standard MOU by will be placed in the docket and, except
of automated collection techniques or December 10, 2018, to ensure that the for those submitted as ‘‘Confidential
other forms of information technology. Agency considers your comment on this Submissions,’’ publicly viewable at
Consideration will be given to draft MOU before it begins work on the https://www.regulations.gov or at the
comments and suggestions submitted final version of the MOU. Submit either Dockets Management Staff between 9
within 60 days of this publication. electronic or written comments on a.m. and 4 p.m., Monday through
information collection issues under the Friday.
Robert A. Sargis, Paperwork Reduction Act of 1995 by • Confidential Submissions—To
Reports Clearance Officer. December 10, 2018 (see the ‘‘Paperwork submit a comment with confidential
[FR Doc. 2018–19561 Filed 9–7–18; 8:45 am] Reduction Act of 1995’’ section of this information that you do not wish to be
BILLING CODE 4184–01–P document). made publicly available, submit your
ADDRESSES: You may submit comments comments only as a written/paper
on the MOU at any time as follows: submission. You should submit two
DEPARTMENT OF HEALTH AND copies total. One copy will include the
HUMAN SERVICES Electronic Submissions information you claim to be confidential
Submit electronic comments in the with a heading or cover note that states
Food and Drug Administration following way: ‘‘THIS DOCUMENT CONTAINS
[Docket No. FDA–2018–N–3065] • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The
https://www.regulations.gov. Follow the Agency will review this copy, including
Memorandum of Understanding instructions for submitting comments. the claimed confidential information, in
Addressing Certain Distributions of Comments submitted electronically, its consideration of comments. The
Compounded Drug Products Between including attachments, to https:// second copy, which will have the
the States and the Food and Drug www.regulations.gov will be posted to claimed confidential information
Administration; Revised Draft; the docket unchanged. Because your redacted/blacked out, will be available
Availability comment will be made public, you are for public viewing and posted on
solely responsible for ensuring that your https://www.regulations.gov. Submit
AGENCY: Food and Drug Administration, both copies to the Dockets Management
comment does not include any
HHS. Staff. If you do not wish your name and
confidential information that you or a
ACTION:Notice of availability; third party may not wish to be posted, contact information to be made publicly
withdrawal. such as medical information, your or available, you can provide this
anyone else’s Social Security number, or information on the cover sheet and not
SUMMARY: The Food and Drug
confidential business information, such in the body of your comments and you
Administration (FDA or the Agency) is
as a manufacturing process. Please note must identify this information as
announcing the availability for public
that if you include your name, contact ‘‘confidential.’’ Any information marked
comment of a revised draft standard
information, or other information that as ‘‘confidential’’ will not be disclosed
memorandum of understanding (MOU)
identifies you in the body of your except in accordance with 21 CFR 10.20
entitled ‘‘Memorandum of
comments, that information will be and other applicable disclosure law. For
Understanding Addressing Certain more information about FDA’s posting
Distributions of Compounded Drug posted on https://www.regulations.gov.
Products Between the State of [insert • If you want to submit a comment of comments to public dockets, see 80
with confidential information that you FR 56469, September 18, 2015, or access
State] and the U.S. Food and Drug the information at: https://www.gpo.gov/
Administration’’ (revised draft standard do not wish to be made available to the
public, submit the comment as a fdsys/pkg/FR-2015-09-18/pdf/2015-
MOU). The revised draft standard MOU 23389.pdf.
describes the responsibilities of a State written/paper submission and in the
manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
that chooses to sign the MOU in read background documents or the
investigating and responding to Submissions’’ and ‘‘Instructions’’).
electronic and written/paper comments
complaints related to compounded drug Written/Paper Submissions received, go to https://
products compounded in the State and Submit written/paper submissions as www.regulations.gov and insert the
distributed outside the State and in follows: docket number, found in brackets in the
addressing the interstate distribution of • Mail/Hand delivery/Courier (for heading of this document, into the
inordinate amounts of compounded written/paper submissions): Dockets ‘‘Search’’ box and follow the prompts
drug products. Management Staff (HFA–305), Food and and/or go to the Dockets Management
FDA is also announcing the Drug Administration, 5630 Fishers Staff, 5630 Fishers Lane, Rm. 1061,
withdrawal of an earlier draft standard Lane, Rm. 1061, Rockville, MD 20852. Rockville, MD 20852.
MOU entitled ‘‘Memorandum of • For written/paper comments Submit written requests for single
Understanding Addressing Certain submitted to the Dockets Management copies of the draft MOU to the Division
Distributions of Compounded Human Staff, FDA will post your comment, as of Drug Information, Center for Drug
Drug Products Between the State of well as any attachments, except for Evaluation and Research, Food and
[insert State] and the U.S. Food and information submitted, marked and Drug Administration, 10001 New
daltland on DSKBBV9HB2PROD with NOTICES
Drug Administration,’’ which was identified, as confidential, if submitted Hampshire Ave., Hillandale Building,
issued in February 2015 (2015 draft as detailed in ‘‘Instructions.’’ 4th Floor, Silver Spring, MD 20993–
standard MOU). The 2015 draft standard Instructions: All submissions received 0002. Send one self-addressed adhesive
MOU is superseded by the revised draft must include the Docket No. FDA– label to assist that office in processing
standard MOU. 2018–N–3065 for ‘‘Memorandum of your requests. See the SUPPLEMENTARY
DATES: FDA is withdrawing its draft Understanding Addressing Certain INFORMATION section for electronic
standard MOU that published on Distributions of Compounded Drug access to the draft document.
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Document Created: 2018-09-08 00:42:54
Document Modified: 2018-09-08 00:42:54
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| FR Citation | 83 FR 45630 |
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