80 FR 53811 - Agency Information Collection Activities: Proposed Collection: Public Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration Federal Register Volume 80, Issue 173 (September 8, 2015)
Health Resources and Services Administration
Federal Register Volume 80, Issue 173 (September 8, 2015)
| Page Range | 53811-53812 | |
| FR Document | 2015-22545 |
[Federal Register Volume 80, Number 173 (Tuesday, September 8, 2015)] [Notices] [Pages 53811-53812] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-22545] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Public Comment Request AGENCY: Health Resources and Services Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR. DATES: Comments on this Information Collection Request must be received no later than November 9, 2015. ADDRESSES: Submit your comments to [email protected] or mail the HRSA Information Collection Clearance Officer, Room 10C-03, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email [email protected] or call the HRSA Information Collection Clearance Officer at (301) 443-1984. SUPPLEMENTARY INFORMATION: When submitting comments or requesting information, please include the information request collection title for reference. Information Collection Request Title: The Maternal, Infant, and Early Childhood Home Visiting Program Performance Measurement Information System. OMB No. 0906-xxxx--New Abstract: The Maternal, Infant, and Early Childhood Home Visiting Program (MIECHV), administered by HRSA in partnership with the Administration for Children and Families (ACF), supports voluntary, evidence-based home visiting services during pregnancy and to parents with young children up to kindergarten entry. States and Tribal entities are eligible to receive funding from the MIECHV Program and have the flexibility to tailor the program to serve the specific needs of their communities. [[Page 53812]] Need and Proposed Use of the Information: HRSA will use the proposed information to demonstrate program accountability and continuously monitor and provide oversight to Home Visiting Program grantees. The information will also be used to provide quality improvement guidance and technical assistance to grantees and help inform the development of early childhood systems at the national, state, and local level. HRSA is seeking to collect demographic, service utilization, and select clinical indicators for participants enrolled in home visiting services. In addition, HRSA will collect a set of standardized performance and outcome indicators that correspond with the statutorily identified benchmark areas. Demographic, Service Utilization, and Clinical Indicators Data These data will describe the population served by the MIECHV Program, including the unduplicated count of the number of participants and participant groups by primary insurance coverage. These data will provide other socio-demographic characteristics of program participants and their utilization of services, such as program retention. Additionally, these data will describe several select clinical indicators of program participants, such as the percent of eligible participants who deliver their child preterm. This information will be collected from participants once, at enrollment in home visiting services and aggregated and reported to HRSA by state/territory grantees once annually. Performance and Outcome Benchmark Data These data constitute a discrete set of standardized performance and outcome indicators that correspond with the statutorily identified benchmark areas. These data will provide aggregate totals, percentages, and rates for performance and outcome indicators that are salient to the MIECHV Program, home visiting services more generally, and the at- risk populations served. These data will be collected from participants based on the appropriate measurement period defined for each measure and aggregated and reported to HRSA by state/territory grantees once annually. This information will be used to demonstrate accountability with legislative and programmatic requirements. It will also be used to monitor and provide continued oversight for grantee performance and to target technical assistance resources to grantees. In the future, it is anticipated the MIECHV funding decisions may be allocated based on grantee performance, including on benchmark performance areas. Likely Respondents: Home Visiting Program grantees. Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose or provide the information requested. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information; to search data sources; to complete and review the collection of information; and to transmit or otherwise disclose the information. The total annual burden hours estimated for this Information Collection Request are summarized in the table below. Total Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Average Number of Number of Total burden per Total burden Form name respondents responses per responses response (in hours respondent hours) ---------------------------------------------------------------------------------------------------------------- Form 1: Demographic, Service 56 1 56 650 36,400 Utilization, and Clinical Indicators Data............ Performance and Outcome 56 1 56 200 11,200 Benchmark Data............. ------------------------------------------------------------------------------- Total................... 56 .............. 56 .............. 47,600 ---------------------------------------------------------------------------------------------------------------- HHS specifically requests comments on (1) the necessity and utility of the proposed information collection for the proper performance of the agency's functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. Jackie Painter, Director, Division of the Executive Secretariat. [FR Doc. 2015-22545 Filed 9-4-15; 8:45 am] BILLING CODE 4165-15-P
![Federal Register / Vol. 80, No. 173 / Tuesday, September 8, 2015 / Notices 53811
second edition SE FAQ guidance. Based www.regulations.gov. As a matter of DEPARTMENT OF HEALTH AND
on the comments received on the Agency practice, FDA generally does HUMAN SERVICES
September 2011 draft guidance and the not post comments submitted by
March 2015 final guidance, we are now individuals in their individual capacity Health Resources and Services
issuing the second edition FAQ final on http://www.regulations.gov. This is Administration
guidance. determined by information indicating
The second edition FAQ guidance Agency Information Collection
that the submission is written by an Activities: Proposed Collection: Public
describes FDA’s current thinking on individual, for example, the comment is
whether and when a change to a tobacco Comment Request
identified with the category ‘‘Individual
product’s label, product quantity in the Consumer’’ under the field titled AGENCY: Health Resources and Services
package, additives, or specifications ‘‘Category (Required),’’ on the ‘‘Your Administration, HHS.
renders that product a ‘‘new tobacco Information’’ page on http:// ACTION: Notice.
product’’ subject to premarket review. It
www.regulations.gov. For this
explains that a manufacturer may SUMMARY: In compliance with the
document, however, FDA will not be requirement for opportunity for public
submit streamlined SE reports for
certain modifications to labels and following this general practice. Instead, comment on proposed data collection
changes to product quantity. The FDA will post on http:// projects (Section 3506(c)(2)(A) of the
guidance also explains FDA’s plans and www.regulations.gov comments to this Paperwork Reduction Act of 1995), the
processes for review of the streamlined docket that have been submitted by Health Resources and Services
SE reports. Finally, this guidance individuals in their individual capacity. Administration (HRSA) announces
responds to several questions that have If you wish to submit any information plans to submit an Information
been raised about the SE process more under a claim of confidentiality, please Collection Request (ICR), described
generally. refer to 21 CFR 10.20. below, to the Office of Management and
The guidance represents the current Budget (OMB). Prior to submitting the
C. Information Identifying the Person
thinking of FDA on this topic. It does ICR to OMB, HRSA seeks comments
Submitting the Comment
not establish any rights for any person from the public regarding the burden
and is not binding on FDA or the public. Please note that your name, contact estimate, below, or any other aspect of
You can use an alternative approach if information, and other information the ICR.
it satisfies the requirements of the identifying you will be posted on http:// DATES: Comments on this Information
applicable statutes and regulations. www.regulations.gov if you include that Collection Request must be received no
II. Paperwork Reduction Act of 1995 information in the body of your later than November 9, 2015.
comments. For electronic comments ADDRESSES: Submit your comments to
This guidance refers to previously paperwork@hrsa.gov or mail the HRSA
submitted to http://
approved information collections. These Information Collection Clearance
collections of information are subject to www.regulations.gov, FDA will post the
body of your comment on http:// Officer, Room 10C–03, Parklawn
review by the Office of Management and Building, 5600 Fishers Lane, Rockville,
Budget (OMB) under the Paperwork www.regulations.gov along with your
state/province and country (if MD 20857.
Reduction Act of 1995 (44 U.S.C. 3501– FOR FURTHER INFORMATION CONTACT: To
3520). The collections of information in provided), the name of your
representative (if any), and the category request more information on the
sections 905(j) and 910 of the FD&C Act proposed project or to obtain a copy of
(21 U.S.C. 387e(j) and 387j, identifying you (e.g., individual,
consumer, academic, industry). For the data collection plans and draft
respectively), as amended by the instruments, email paperwork@hrsa.gov
Tobacco Control Act (Pub. L. 111–31), written submissions submitted to the
or call the HRSA Information Collection
have been approved under OMB control Division of Dockets Management, FDA
Clearance Officer at (301) 443–1984.
number 0910–0673; the collections of will post the body of your comments on
SUPPLEMENTARY INFORMATION: When
information in 21 CFR part 25 have been http://www.regulations.gov, but you can
submitting comments or requesting
approved under OMB control number put your name and/or contact
information, please include the
0910–0322. information on a separate cover sheet information request collection title for
III. Comments and not in the body of your comments. reference.
IV. Electronic Access Information Collection Request Title:
A. General Information About
The Maternal, Infant, and Early
Submitting Comments Persons with access to the Internet Childhood Home Visiting Program
Interested persons may submit either may obtain an electronic version of the Performance Measurement Information
electronic comments regarding this guidance at either http:// System.
document to http://www.regulations.gov www.regulations.gov or http:// OMB No. 0906–xxxx—New
or written comments to the Division of www.fda.gov/TobaccoProducts/ Abstract: The Maternal, Infant, and
Dockets Management (see ADDRESSES). It GuidanceComplianceRegulatory Early Childhood Home Visiting Program
is only necessary to send one set of Information/default.htm. (MIECHV), administered by HRSA in
comments. Identify comments with the partnership with the Administration for
Dated: August 27, 2015. Children and Families (ACF), supports
asabaliauskas on DSK5VPTVN1PROD with NOTICES
docket number found in brackets in the
heading of this document. Leslie Kux, voluntary, evidence-based home visiting
Associate Commissioner for Policy. services during pregnancy and to
B. Public Availability of Comments parents with young children up to
[FR Doc. 2015–22494 Filed 9–4–15; 8:45 am]
Received comments may be seen in BILLING CODE 4164–01–P
kindergarten entry. States and Tribal
the Division of Dockets Management entities are eligible to receive funding
between 9 a.m. and 4 p.m., Monday from the MIECHV Program and have the
through Friday, and will be posted to flexibility to tailor the program to serve
the docket at http:// the specific needs of their communities.
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![53812 Federal Register / Vol. 80, No. 173 / Tuesday, September 8, 2015 / Notices
Need and Proposed Use of the retention. Additionally, these data will monitor and provide continued
Information: HRSA will use the describe several select clinical oversight for grantee performance and to
proposed information to demonstrate indicators of program participants, such target technical assistance resources to
program accountability and as the percent of eligible participants grantees. In the future, it is anticipated
continuously monitor and provide who deliver their child preterm. This the MIECHV funding decisions may be
oversight to Home Visiting Program information will be collected from allocated based on grantee performance,
grantees. The information will also be participants once, at enrollment in including on benchmark performance
used to provide quality improvement home visiting services and aggregated areas.
guidance and technical assistance to and reported to HRSA by state/territory Likely Respondents: Home Visiting
grantees and help inform the grantees once annually. Program grantees.
development of early childhood systems
Performance and Outcome Benchmark Burden Statement: Burden in this
at the national, state, and local level.
Data context means the time expended by
HRSA is seeking to collect demographic,
service utilization, and select clinical These data constitute a discrete set of persons to generate, maintain, retain,
indicators for participants enrolled in standardized performance and outcome disclose or provide the information
home visiting services. In addition, indicators that correspond with the requested. This includes the time
HRSA will collect a set of standardized statutorily identified benchmark areas. needed to review instructions; to
performance and outcome indicators These data will provide aggregate totals, develop, acquire, install and utilize
that correspond with the statutorily percentages, and rates for performance technology and systems for the purpose
identified benchmark areas. and outcome indicators that are salient of collecting, validating and verifying
to the MIECHV Program, home visiting information, processing and
Demographic, Service Utilization, and services more generally, and the at-risk maintaining information, and disclosing
Clinical Indicators Data populations served. These data will be and providing information; to train
These data will describe the collected from participants based on the personnel and to be able to respond to
population served by the MIECHV appropriate measurement period a collection of information; to search
Program, including the unduplicated defined for each measure and aggregated data sources; to complete and review
count of the number of participants and and reported to HRSA by state/territory the collection of information; and to
participant groups by primary insurance grantees once annually. transmit or otherwise disclose the
coverage. These data will provide other This information will be used to information. The total annual burden
socio-demographic characteristics of demonstrate accountability with hours estimated for this Information
program participants and their legislative and programmatic Collection Request are summarized in
utilization of services, such as program requirements. It will also be used to the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of Total burden per Total burden
Form name responses per
respondents responses response hours
respondent (in hours)
Form 1:
Demographic, Service Utilization, and Clinical Indica-
tors Data .................................................................... 56 1 56 650 36,400
Performance and Outcome Benchmark Data .............. 56 1 56 200 11,200
Total ....................................................................... 56 ........................ 56 ........................ 47,600
HHS specifically requests comments DEPARTMENT OF HEALTH AND (IHS) is submitting to the Office of
on (1) the necessity and utility of the HUMAN SERVICES Management and Budget (OMB) a
proposed information collection for the request for an extension of a previously
proper performance of the agency’s Indian Health Service approved collection of information
functions, (2) the accuracy of the titled, ‘‘Addendum to Declaration for
[OMB NO. 0917–0028] Federal Employment, Child Care and
estimated burden, (3) ways to enhance
the quality, utility, and clarity of the Indian Child Care Worker Positions,’’
Request for Public Comment: 30-Day
information to be collected, and (4) the Office of Management and Budget
Proposed Information Collection:
use of automated collection techniques (OMB) Control Number 0917–0028,
Addendum to Declaration for Federal
or other forms of information which expires November 30, 2015.
Employment, Child Care and Indian
technology to minimize the information This previously approved information
Child Care Worker Positions
collection burden. collection project was last published in
AGENCY: Indian Health Service, HHS. the Federal Register (80 FR 43100) on
July 21, 2015, and allowed 60 days for
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Jackie Painter, ACTION:Notice and request for
Director, Division of the Executive Secretariat. comments. Request for extension of public comment, as required by 44
[FR Doc. 2015–22545 Filed 9–4–15; 8:45 am] approval. U.S.C. 3506(c)(2)(A). The IHS received
no comments regarding this collection.
BILLING CODE 4165–15–P
SUMMARY: In compliance with the The purpose of this notice is to solicit
Paperwork Reduction Act of 1995, public comments on specific aspects of
Public Law (Pub. L.) 104–13 [44 United the proposed information collection,
States Code (U.S.C.) section which are to be submitted directly to
3507(a)(1)(D)], the Indian Health Service OMB for a 30 day period.
VerDate Sep<11>2014 17:18 Sep 04, 2015 Jkt 235001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E:\FR\FM\08SEN1.SGM 08SEN1](https://thefederalregister.org/doc/80_FR_53984/page/2.svg)
Document Created: 2018-02-26 10:13:50
Document Modified: 2018-02-26 10:13:50
| 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 | |
| Action | Notice. | |
| Dates | Comments on this Information Collection Request must be received no later than November 9, 2015. | |
| Contact | To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email [email protected] or call the HRSA Information Collection Clearance Officer at (301) 443-1984. | |
| FR Citation | 80 FR 53811 |
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