81_FR_62686 81 FR 62511 - Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Maternal, Infant, and Early Childhood Home Visiting Program Cost Reporting Pilot Study

81 FR 62511 - Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Maternal, Infant, and Early Childhood Home Visiting Program Cost Reporting Pilot Study

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration

Federal Register Volume 81, Issue 175 (September 9, 2016)

Page Range62511-62512
FR Document2016-21734

In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.

Federal Register, Volume 81 Issue 175 (Friday, September 9, 2016)
[Federal Register Volume 81, Number 175 (Friday, September 9, 2016)]
[Notices]
[Pages 62511-62512]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-21734]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Submission to OMB for 
Review and Approval; Public Comment Request; Maternal, Infant, and 
Early Childhood Home Visiting Program Cost Reporting Pilot Study

AGENCY: Health Resources and Services Administration (HRSA), Department 
of Health and Human Services.

ACTION: Notice.

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

SUMMARY: In compliance with section 3507(a)(1)(D) of the Paperwork 
Reduction Act of 1995, HRSA has submitted an Information Collection 
Request (ICR) to the Office of Management and Budget (OMB) for review 
and approval. Comments submitted during the first public review of this 
ICR will be provided to OMB. OMB will accept further comments from

[[Page 62512]]

the public during the review and approval period.

DATES: Comments on this ICR should be received no later than October 
11, 2016.

ADDRESSES: Submit your comments, including the ICR Title, to the desk 
officer for HRSA, either by email to OIRA_submission@omb.eop.gov or by 
fax to 202-395-5806.

FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance 
requests submitted to OMB for review, email the HRSA Information 
Collection Clearance Officer at paperwork@hrsa.gov or call (301) 443-
1984.

SUPPLEMENTARY INFORMATION: 
    Information Collection Request Title: Maternal, Infant, and Early 
Childhood Home Visiting Program Cost Reporting Pilot Study
    OMB No. 0906-xxxx--NEW
    Abstract: The Maternal, Infant, and Early Childhood Home Visiting 
Program (Federal Home Visiting Program), administered by HRSA in 
partnership with the Administration for Children and Families, supports 
voluntary, evidence-based home visiting services during pregnancy and 
to parents with young children up to kindergarten entry. States, Tribal 
entities, and certain nonprofit organizations are eligible to receive 
funding from the Federal Home Visiting Program and have the flexibility 
to tailor the program to serve the specific needs of their communities. 
Funding recipients may subaward grant funds to organizations, otherwise 
known as Local Implementing Agencies (LIAs), in order to provide 
services to eligible families in at-risk communities.
    Need and Proposed Use of the Information: This information 
collection is requested to conduct a pilot study to test the 
reliability of a standardized cost reporting tool for the provision of 
evidence-based home visiting services. The information collected will 
be used to: Test the reliability and feasibility of implementing a 
proposed set of standardized cost metrics and organizational 
characteristics across various contexts; estimate preliminary total 
costs for implementing evidence-based home visiting services, including 
ranges, and; further refine cost metrics and the cost reporting tool 
based on feedback received through the pilot study. Proposed standard 
cost metrics have been developed based on a review of the existing 
literature for measures of home visiting costs, as well as from ongoing 
discussions with developers of evidence-based home visiting models.
    HRSA received comments from one respondent during the public 
comment period which estimated the hourly burden per response to be 16 
hours. The estimated burden has been revised to reflect this feedback. 
Further, the commenter expressed an interest in using the tool to 
analyze the cost-benefit and overall value of home visiting programs. 
While the cost reporting tool may be useful in collecting information 
that will lead to additional cost-benefit analyses, those analyses are 
outside the scope of the current project. A full response to the 
comments can be accessed in Part A of the Supporting Statement.
    Likely Respondents: Organizations, including LIAs providing 
evidence-based home visiting services through the Federal Home Visiting 
Program.
    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 ICR 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)
----------------------------------------------------------------------------------------------------------------
Cost Elements Table.............              90               1              90            15.5           1,395
Organizational Characteristics                90               1              90             0.5              45
 Table..........................
                                 -------------------------------------------------------------------------------
    Total.......................          \1\ 90  ..............              90  ..............           1,440
----------------------------------------------------------------------------------------------------------------
\1\ The same 90 individuals complete the Cost Elements Table and the Organizational Characteristics Table.


Jason E. Bennett,
Director, Division of the Executive Secretariat.
[FR Doc. 2016-21734 Filed 9-8-16; 8:45 am]
 BILLING CODE 4165-15-P



                                                                                     Federal Register / Vol. 81, No. 175 / Friday, September 9, 2016 / Notices                                                                                        62511

                                                    microbiological laboratory technologist                        collection burden resulting from the                                         one-time burden of 160 hours
                                                    would work an average of 76.5 hours                            need to conduct a controlled study in                                        annualized over 3 years (160/3 = 53.3),
                                                    annually (153 infants × 0.5 hours per                          order to gather data to substantiate a                                       the total annual record keeping burden
                                                    infant = 76.5 hours) to prepare and                            new structure/function claim, or a                                           is 219.3 hours (166 + 53.3 = 219.3).
                                                    analyze fecal samples taken from infants                       structure/function claim that lacks                                          There are no estimated capital costs or
                                                    in the controlled study. All estimates                         sufficient prior evidence, for a total of                                    operating and maintenance costs
                                                    are shown in table 2. Therefore, a total                       166 total annual hours (156 + 10 = 166)                                      associated with this information
                                                    of 156 additional annual burden hours                          for the upkeep and generation of                                             collection.
                                                    (3 + 38.25 + 38.25 + 76.5 = 156) are                           information used to substantiate
                                                    estimated to account for the information                       structure/function claims. Including the

                                                                                             TABLE 1—ESTIMATED ONE-TIME HOURLY RECORDKEEPING BURDEN
                                                                                                                                                                   First year
                                                                                                                                        Number of                                                                         Hours per
                                                                           Recordkeeping activity                                                                frequency of                Total records                                        Total hours
                                                                                                                                       respondents                                                                         record
                                                                                                                                                                recordkeeping

                                                                                                                                   First Year Hourly Burden

                                                    Assembling Records Related to Substantiation of Existing
                                                      Structure/Function Claims ................................................                        10                            1                         10                        16               160

                                                         Total First Year Only Recordkeeping Burden ..............                   ........................   ........................    ........................   ........................           *160


                                                                                                                     TABLE 2—RECORDKEEPING BURDEN
                                                                                                                                                      Annual
                                                                                                                         Number of
                                                                     Recordkeeping activity                                                        frequency of               Total records                   Hours per record                    Total hours
                                                                                                                        respondents               recordkeeping

                                                                                                                                   Recurring Hourly Burden

                                                    *Annualized Recordkeeping Burden from Table 1                                         10                          1                         5.3     1 ....................................            53.3
                                                    Maintaining Records Related to Substantiation of                                      10                          1                         10      1 ....................................             10
                                                      Structure/Function Claims.
                                                    Controlled Study—Principal Investigator ..............                                  1                       1                            1      3 ....................................               3
                                                    Controlled Study—Sample Collector ....................                                  1                     153                          153      0.25 (15 minutes) .........                      38.25
                                                    Controlled Study—Nurse/Heath Care Profes-                                               1                     153                          153      0.25 (15 minutes) .........                      38.25
                                                      sional.
                                                    Controlled Study—Lab Tech ................................                              1                     153                          153      0.5 (30 minutes) ...........                      76.5

                                                         Total Recordkeeping Burden ........................          ........................   ........................    ........................   .......................................          219.3



                                                      Before the proposed information                              persons between 9 a.m. and 4 p.m.,                                           DEPARTMENT OF HEALTH AND
                                                    collection provisions contained in this                        Monday through Friday; they are also                                         HUMAN SERVICES
                                                    draft guidance become effective, we will                       available electronically at http://
                                                    publish a notice in the Federal Register                       www.regulations.gov.                                                         Health Resources and Services
                                                    announcing OMB’s decision to approve,                          1. Moro, G., F. Mosca, V. Miniello, et al.,
                                                                                                                                                                                                Administration
                                                    modify, or disapprove the proposed                                  ‘‘Effects of a New Mixture of Prebiotics
                                                    information collection provisions. An                               on Faecal Flora and Stools in Term                                      Agency Information Collection
                                                    Agency may not conduct or sponsor,                                  Infants.’’ Acta Paediatrica, 2003.                                      Activities: Submission to OMB for
                                                    and a person is not required to respond                             Supplement September 1991(441): pp.                                     Review and Approval; Public Comment
                                                    to, a collection of information unless it                           77–79.                                                                  Request; Maternal, Infant, and Early
                                                    displays a currently valid OMB control                         2. Boehm, G., M. Lidestri, P. Casetta,, et al.,                              Childhood Home Visiting Program
                                                                                                                        ‘‘Supplementation of a Bovine Milk                                      Cost Reporting Pilot Study
                                                    number.                                                             Formula with an Oligosaccharide
                                                    III. Electronic Access                                              Mixture Increases Counts of Faecal                                      AGENCY: Health Resources and Services
                                                                                                                        Bifidobacteria in Preterm Infants.’’                                    Administration (HRSA), Department of
                                                      Persons with access to the Internet                               Archives of Disease in Childhood Fetal                                  Health and Human Services.
                                                    may obtain the draft guidance at either                             and Neonatal Edition, 2002. 86(3): pp.                                  ACTION: Notice.
                                                    http://www.fda.gov/FoodGuidances or                                 F178–181.
                                                    http://www.regulations.gov. Use the                            3. Pickering, L.K., D.M. Granoff, J.R.                                       SUMMARY:   In compliance with section
                                                                                                                        Erickson, et al., ‘‘Modulation of the                                   3507(a)(1)(D) of the Paperwork
                                                    FDA Web site listed in the previous
asabaliauskas on DSK3SPTVN1PROD with NOTICES




                                                                                                                        Immune System by Human Milk and
                                                    sentence to find the most current                                   Infant Formula Containing Nucleotides.’’
                                                                                                                                                                                                Reduction Act of 1995, HRSA has
                                                    version of the guidance.                                            Pediatrics, 1998. 101(2): pp. 242–249.                                  submitted an Information Collection
                                                                                                                                                                                                Request (ICR) to the Office of
                                                    IV. References                                                   Dated: August 29, 2016.                                                    Management and Budget (OMB) for
                                                      The following references are on                              Leslie Kux,                                                                  review and approval. Comments
                                                    display in the Division of Dockets                             Associate Commissioner for Policy.                                           submitted during the first public review
                                                    Management (see ADDRESSES) and are                             [FR Doc. 2016–21725 Filed 9–8–16; 8:45 am]                                   of this ICR will be provided to OMB.
                                                    available for viewing by interested                            BILLING CODE 4164–01–P                                                       OMB will accept further comments from


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                                                    62512                                 Federal Register / Vol. 81, No. 175 / Friday, September 9, 2016 / Notices

                                                    the public during the review and                                          specific needs of their communities.                           commenter expressed an interest in
                                                    approval period.                                                          Funding recipients may subaward grant                          using the tool to analyze the cost-benefit
                                                    DATES: Comments on this ICR should be                                     funds to organizations, otherwise                              and overall value of home visiting
                                                    received no later than October 11, 2016.                                  known as Local Implementing Agencies                           programs. While the cost reporting tool
                                                    ADDRESSES: Submit your comments,                                          (LIAs), in order to provide services to                        may be useful in collecting information
                                                    including the ICR Title, to the desk                                      eligible families in at-risk communities.                      that will lead to additional cost-benefit
                                                    officer for HRSA, either by email to                                         Need and Proposed Use of the                                analyses, those analyses are outside the
                                                    OIRA_submission@omb.eop.gov or by                                         Information: This information collection                       scope of the current project. A full
                                                    fax to 202–395–5806.                                                      is requested to conduct a pilot study to                       response to the comments can be
                                                    FOR FURTHER INFORMATION CONTACT: To                                       test the reliability of a standardized cost                    accessed in Part A of the Supporting
                                                    request a copy of the clearance requests                                  reporting tool for the provision of                            Statement.
                                                    submitted to OMB for review, email the                                    evidence-based home visiting services.                            Likely Respondents: Organizations,
                                                    HRSA Information Collection Clearance                                     The information collected will be used                         including LIAs providing evidence-
                                                    Officer at paperwork@hrsa.gov or call                                     to: Test the reliability and feasibility of                    based home visiting services through
                                                    (301) 443–1984.                                                           implementing a proposed set of                                 the Federal Home Visiting Program.
                                                    SUPPLEMENTARY INFORMATION:                                                standardized cost metrics and                                     Burden Statement: Burden in this
                                                      Information Collection Request Title:                                   organizational characteristics across                          context means the time expended by
                                                    Maternal, Infant, and Early Childhood                                     various contexts; estimate preliminary                         persons to generate, maintain, retain,
                                                    Home Visiting Program Cost Reporting                                      total costs for implementing evidence-                         disclose or provide the information
                                                    Pilot Study                                                               based home visiting services, including                        requested. This includes the time
                                                      OMB No. 0906–xxxx—NEW                                                   ranges, and; further refine cost metrics                       needed to review instructions; to
                                                      Abstract: The Maternal, Infant, and                                     and the cost reporting tool based on                           develop, acquire, install and utilize
                                                    Early Childhood Home Visiting Program                                     feedback received through the pilot                            technology and systems for the purpose
                                                    (Federal Home Visiting Program),                                          study. Proposed standard cost metrics                          of collecting, validating and verifying
                                                    administered by HRSA in partnership                                       have been developed based on a review                          information, processing and
                                                    with the Administration for Children                                      of the existing literature for measures of                     maintaining information, and disclosing
                                                    and Families, supports voluntary,                                         home visiting costs, as well as from                           and providing information; to train
                                                    evidence-based home visiting services                                     ongoing discussions with developers of                         personnel and to be able to respond to
                                                    during pregnancy and to parents with                                      evidence-based home visiting models.                           a collection of information; to search
                                                    young children up to kindergarten                                            HRSA received comments from one                             data sources; to complete and review
                                                    entry. States, Tribal entities, and certain                               respondent during the public comment                           the collection of information; and to
                                                    nonprofit organizations are eligible to                                   period which estimated the hourly                              transmit or otherwise disclose the
                                                    receive funding from the Federal Home                                     burden per response to be 16 hours. The                        information. The total annual burden
                                                    Visiting Program and have the flexibility                                 estimated burden has been revised to                           hours estimated for this ICR are
                                                    to tailor the program to serve the                                        reflect this feedback. Further, the                            summarized in the table below.

                                                                                                                    TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
                                                                                                                                                                    Number of                                     Average
                                                                                                                                                 Number of           responses                  Total           burden per              Total burden
                                                                                      Form name                                                 respondents             per                  responses           response                  hours
                                                                                                                                                                    respondent                                   (in hours)

                                                    Cost Elements Table ...........................................................                          90                         1            90                       15.5             1,395
                                                    Organizational Characteristics Table ...................................                                 90                         1            90                        0.5                45

                                                         Total ..............................................................................            1 90     ........................           90      ........................          1,440
                                                       1 The   same 90 individuals complete the Cost Elements Table and the Organizational Characteristics Table.


                                                    Jason E. Bennett,                                                         DEPARTMENT OF HEALTH AND                                       an Information Collection Request (ICR)
                                                    Director, Division of the Executive Secretariat.                          HUMAN SERVICES                                                 to the Office of Management and Budget
                                                    [FR Doc. 2016–21734 Filed 9–8–16; 8:45 am]                                                                                               (OMB) for review and approval.
                                                                                                                              Health Resources and Services                                  Comments submitted during the first
                                                    BILLING CODE 4165–15–P
                                                                                                                              Administration                                                 public review of this ICR will be
                                                                                                                                                                                             provided to OMB. OMB will accept
                                                                                                                              Agency Information Collection                                  further comments from the public
                                                                                                                              Activities: Submission to OMB for                              during the review and approval period.
                                                                                                                              Review and Approval; Public Comment                            DATES: Comments on this ICR should be
                                                                                                                              Request; Small Rural Hospital                                  received no later than October 11, 2016.
                                                                                                                              Transitions Project                                            ADDRESSES: Submit your comments,
asabaliauskas on DSK3SPTVN1PROD with NOTICES




                                                                                                                              AGENCY: Health Resources and Services                          including the ICR Title, to the desk
                                                                                                                              Administration (HRSA), Department of                           officer for HRSA, either by email to
                                                                                                                              Health and Human Services                                      OIRA_submission@omb.eop.gov or by
                                                                                                                              ACTION: Notice.
                                                                                                                                                                                             fax to 202–395–5806.
                                                                                                                                                                                             FOR FURTHER INFORMATION CONTACT: To
                                                                                                                              SUMMARY:  In compliance with Section                           request a copy of the clearance requests
                                                                                                                              3507(a)(1)(D) of the Paperwork                                 submitted to OMB for review, email the
                                                                                                                              Reduction Act of 1995, HRSA submitted                          HRSA Information Collection Clearance


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Document Created: 2018-02-09 13:15:31
Document Modified: 2018-02-09 13:15:31
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesComments on this ICR should be received no later than October 11, 2016.
ContactTo request a copy of the clearance requests submitted to OMB for review, email the HRSA Information Collection Clearance Officer at [email protected] or call (301) 443- 1984.
FR Citation81 FR 62511 

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