81 FR 31641 - Submission for OMB Review; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families Federal Register Volume 81, Issue 97 (May 19, 2016)
Administration for Children and Families
Federal Register Volume 81, Issue 97 (May 19, 2016)
| Page Range | 31641-31642 | |
| FR Document | 2016-11791 |
[Federal Register Volume 81, Number 97 (Thursday, May 19, 2016)] [Notices] [Pages 31641-31642] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-11791] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Submission for OMB Review; Comment Request Title: Tribal Maternal, Infant, and Early Childhood Home Visiting Program Implementation Plan Guidance and Form 1: Demographic and Service Utilization Data. OMB No.: 0970-0389. Description: Social Security Act, Title V, Section 511 (42 U.S.C. 711), as amended by the Medicare Access and Children's Health Insurance Program (CHIP) Reauthorization Act of 2015 (Pub. L. 114-10), created the Maternal, Infant, and Early Childhood Home Visiting Program (MIECHV) and authorized the Secretary of HHS (in Section 511(h)(2)(A)) to award grants to Indian tribes (or a consortium of Indian tribes), tribal organizations, or urban Indian organizations to conduct an early childhood home visiting program. The legislation set aside 3 percent of the total MIECHV program appropriation (authorized in Section 511(j)) for grants to tribal entities. Tribal MIECHV grants, to the greatest extent practicable, are to be consistent with the requirements of the MIECHV grants to states and jurisdictions (authorized in Section 511(c)), and include conducting a needs assessment and establishing quantifiable, measurable benchmarks. The Administration for Children and Families, Office of Child Care and Office of the Deputy Assistant Secretary for Early Childhood Development, in collaboration with the Health Resources and Services Administration, Maternal and Child Health Bureau, awarded grants for the Tribal MIECHV Program. The Tribal MIECHV grant awards support 5- year cooperative agreements to conduct community needs and readiness assessments, plan for and implement high-quality, culturally-relevant, evidence-based home visiting programs in at-risk Tribal communities, and engage in rigorous evaluation activities to build the knowledge base on home visiting among American Indian and Alaska Native populations. In Year 1 of the cooperative agreement, grantees must (1) conduct a comprehensive community needs and readiness assessment and (2) develop a plan to respond to identified needs. Grantees will be required to conduct or update a needs and readiness assessment and develop an implementation plan to respond to those needs, including a plan for [[Page 31642]] demographic and service utilization data, performance measurement, and continuous quality improvement, and participating in or conducting rigorous evaluation activities. Grantees are expected to submit the implementation plan by the end of Year 1 of the grant, with draft submission milestones throughout the first year. As part of the non- competing continuation application for Years 3-5 of the grant, Tribal MIECHV grantees will update their implementation plans as necessary to ensure that the plan accurately reflects activities to be completed throughout the remainder of the grant. Following each year that Tribal MIECHV grantees implement home visiting services, they must also submit Form 1: Demographic and Service Utilization Data. Respondents: Tribal Maternal, Infant, and Early Childhood Home Visiting Program Grantees. (The information collection does not include direct interaction with individuals or families that receive the services). Annual Burden Estimates ---------------------------------------------------------------------------------------------------------------- Number of Average burden Instrument Number of responses per hours per Total burden respondents respondent response hours ---------------------------------------------------------------------------------------------------------------- Tribal Maternal, Infant, and Early Childhood 25 1 1000 25,000 Home Visiting Implementation Plan Guidance..... Tribal MIECHV Form 1 Demographic & Service 25 1 500 12,500 Utilization Data & Service Data................ --------------------------------------------------------------- Estimated Annual Burden Hours:.............. .............. .............. .............. 37,500 ---------------------------------------------------------------------------------------------------------------- Estimated Total Annual Burden Hours: 37,500. Additional Information: Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 330 C Street SW., Washington, DC 20201. Attention Reports Clearance Officer. All requests should be identified by the title of the information collection. Email address: [email protected]. OMB Comment: OMB is required to make a decision concerning 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. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, Email: [email protected], Attn: Desk Officer for the Administration for Children and Families. Robert Sargis, Reports Clearance Officer. [FR Doc. 2016-11791 Filed 5-18-16; 8:45 am] BILLING CODE 4184-01-P
![Federal Register / Vol. 81, No. 97 / Thursday, May 19, 2016 / Notices 31641
to justify the sunk costs associated with acquisition of Airgas are related to the DEPARTMENT OF HEALTH AND
the required investment. bulk liquid oxygen, nitrogen, and argon HUMAN SERVICES
Entry into the retail packaged welding markets, the pipeline oxygen and
gases market would also not be timely, nitrogen businesses and contracts Administration for Children and
likely or sufficient to deter or counteract located at the ASUs are also being Families
the likely adverse competitive effects of divested because they are critical to the
the proposed acquisition. Currently, Air viability, efficiency, and Submission for OMB Review;
Liquide is the only entity capable of competitiveness of each plant. Air Comment Request
filling packaged gases in the relevant Liquide has agreed to divest the Title: Tribal Maternal, Infant, and
geographic markets for retail packaged required facilities, together with all Early Childhood Home Visiting Program
welding gas, all of which are in Alaska. related equipment, customer and supply Implementation Plan Guidance and
A new entrant would be required either contracts, technology, and goodwill, to Form 1: Demographic and Service
to purchase bulk gases and construct a one or more Commission-approved Utilization Data.
fill plant to put the gases in packaged buyers within four months of OMB No.: 0970–0389.
form or to establish a supply network to consummating its transaction with Description: Social Security Act, Title
transport packaged gases from a fill Airgas. V, Section 511 (42 U.S.C. 711), as
plant outside of Alaska to the relevant Any acquirer of the divested assets amended by the Medicare Access and
geographic markets. Because of these must receive the prior approval of the Children’s Health Insurance Program
obstacles, new entry into the relevant Commission. The Commission’s goal in (CHIP) Reauthorization Act of 2015
markets is unlikely to occur. evaluating possible purchasers of (Pub. L. 114–10), created the Maternal,
XI. The Consent Agreement divested assets is to maintain the Infant, and Early Childhood Home
The proposed Consent Agreement is competitive environment that existed Visiting Program (MIECHV) and
designed to eliminate the competitive prior to the acquisition. A proposed authorized the Secretary of HHS (in
concerns raised by Air Liquide’s acquirer of divested assets must not Section 511(h)(2)(A)) to award grants to
proposed acquisition of Airgas in each itself present competitive problems. Indian tribes (or a consortium of Indian
relevant market. Under the terms of the There are a number of parties interested tribes), tribal organizations, or urban
proposed Consent Agreement, Air in purchasing the assets to be divested Indian organizations to conduct an early
Liquide is required to divest sixteen that have the expertise, experience, and childhood home visiting program. The
ASUs, twelve of which are currently financial viability to successfully legislation set aside 3 percent of the
owned and operated by Air Liquide and purchase and manage these assets and total MIECHV program appropriation
four of which are currently owned and retain the current level of competition (authorized in Section 511(j)) for grants
operated by Airgas. The Air Liquide- in the relevant markets. The to tribal entities. Tribal MIECHV grants,
operated ASUs are located in: (1) Commission is therefore satisfied that to the greatest extent practicable, are to
Burlington, Wisconsin; (2) Chattanooga, sufficient potential buyers for the be consistent with the requirements of
Tennessee; (3) Feura Bush, New York; divested assets in each relevant market the MIECHV grants to states and
(4) Holland, Ohio; (5) Mapleton, Illinois; currently exist. jurisdictions (authorized in Section
(6) Middletown, Ohio; (7) Mount The proposed Consent Agreement 511(c)), and include conducting a needs
Vernon, Indiana; (8) Pittsboro, Indiana; incorporates a proposed Order to assessment and establishing
(9) St. Marys, Pennsylvania; (10) Maintain Assets to ensure the continued quantifiable, measurable benchmarks.
Spartanburg, South Carolina; (11) Wake operations of the divestiture assets The Administration for Children and
Forest, North Carolina; and (12) West while a sale is conducted, and for a brief Families, Office of Child Care and Office
Point, Virginia. The Airgas-operated transition period once the Commission of the Deputy Assistant Secretary for
ASUs are located in: (1) Carrollton, approves a buyer for the assets. The Early Childhood Development, in
Kentucky; (2) Gaston, South Carolina; proposed Order to Maintain Assets also collaboration with the Health Resources
(3) Lawton, Oklahoma; and (4) allows the Commission to appoint an and Services Administration, Maternal
Mulberry, Arkansas. Air Liquide is also interim monitor to oversee compliance and Child Health Bureau, awarded
required to divest both of its nitrous with all the obligations and grants for the Tribal MIECHV Program.
oxide plants, one located in Denora, responsibilities under the proposed The Tribal MIECHV grant awards
Pennsylvania and the other in Order and requires Air Liquide to support 5-year cooperative agreements
Richmond, California. Air Liquide must execute an agreement conferring upon to conduct community needs and
also divest four co-located liquid carbon the interim monitor all of the rights, readiness assessments, plan for and
dioxide and dry ice facilities, which powers, and authorities necessary to implement high-quality, culturally-
comprise its entire dry ice business, permit the monitor to ensure the relevant, evidence-based home visiting
located in: (1) Borger, Texas; (2) Galva, continued health and competitiveness programs in at-risk Tribal communities,
Iowa; (3) Sioux City, Iowa; (4) and of the divested businesses. and engage in rigorous evaluation
Martinez, California. The purpose of this analysis is to activities to build the knowledge base
Additionally, Air Liquide will divest facilitate public comment on the on home visiting among American
two liquid carbon dioxide-only facilities proposed Consent Agreement, and it is Indian and Alaska Native populations.
in Madison, Mississippi and not intended to constitute an official In Year 1 of the cooperative
Washington, Indiana along with the interpretation of the proposed Consent agreement, grantees must (1) conduct a
associated rail depot located in Fort comprehensive community needs and
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Agreement or to modify its terms in any
Meade, Florida. Lastly, Air Liquide will way. readiness assessment and (2) develop a
divest Airgas’s retail packaged welding plan to respond to identified needs.
gas and hardgoods stores located in By direction of the Commission. Grantees will be required to conduct or
Anchorage, Fairbanks, and Kenai, Donald S. Clark, update a needs and readiness
Alaska. Additionally, with regard to the Secretary. assessment and develop an
ASU assets, although the [FR Doc. 2016–11763 Filed 5–18–16; 8:45 am] implementation plan to respond to
anticompetitive effects of Air Liquide’s BILLING CODE 6750–01–P those needs, including a plan for
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![31642 Federal Register / Vol. 81, No. 97 / Thursday, May 19, 2016 / Notices
demographic and service utilization non-competing continuation application visiting services, they must also submit
data, performance measurement, and for Years 3–5 of the grant, Tribal Form 1: Demographic and Service
continuous quality improvement, and MIECHV grantees will update their Utilization Data.
participating in or conducting rigorous implementation plans as necessary to Respondents: Tribal Maternal, Infant,
evaluation activities. Grantees are ensure that the plan accurately reflects and Early Childhood Home Visiting
expected to submit the implementation activities to be completed throughout Program Grantees. (The information
plan by the end of Year 1 of the grant, the remainder of the grant. collection does not include direct
with draft submission milestones Following each year that Tribal interaction with individuals or families
throughout the first year. As part of the MIECHV grantees implement home that receive the services).
ANNUAL BURDEN ESTIMATES
Number of Average
Number of Total burden
Instrument responses per burden hours
respondents hours
respondent per response
Tribal Maternal, Infant, and Early Childhood Home Visiting Implementation
Plan Guidance .............................................................................................. 25 1 1000 25,000
Tribal MIECHV Form 1 Demographic & Service Utilization Data & Service
Data .............................................................................................................. 25 1 500 12,500
Estimated Annual Burden Hours: ............................................................. ........................ ........................ ........................ 37,500
Estimated Total Annual Burden ACTION:Notice; renewal of advisory The Committee shall consist of a core
Hours: 37,500. committee. of 17 voting members including the
Additional Information: Copies of the Chair. Members and the Chair are
proposed collection may be obtained by SUMMARY: The Food and Drug selected by the Commissioner or
writing to the Administration for Administration (FDA) is announcing the designee from among authorities
Children and Families, Office of renewal of the Blood Products Advisory knowledgeable in the fields of clinical
Planning, Research and Evaluation, 330 Committee by the Commissioner of and administrative medicine,
C Street SW., Washington, DC 20201. Food and Drugs (the Commissioner). hematology, immunology, blood
Attention Reports Clearance Officer. All The Commissioner has determined that banking, surgery, internal medicine,
requests should be identified by the title it is in the public interest to renew the biochemistry, engineering, biological
of the information collection. Email Blood Products Advisory Committee for and physical sciences, biotechnology,
address: infocollection@acf.hhs.gov. an additional 2 years beyond the charter computer technology, statistics,
OMB Comment: OMB is required to expiration date. The new charter will be epidemiology, sociology/ethics, and
make a decision concerning the in effect until May 13, 2018. other related professions. Members will
collection of information between 30 DATES: Authority for the Blood Products be invited to serve for overlapping terms
and 60 days after publication of this Advisory Committee will expire on May of up to 4 years. Almost all non-Federal
document in the Federal Register. 13, 2016, unless the Commissioner members of this committee serve as
Therefore, a comment is best assured of formally determines that renewal is in Special Government Employees. The
having its full effect if OMB receives it the public interest. core of voting members may include one
within 30 days of publication. Written FOR FURTHER INFORMATION CONTACT: technically qualified member, selected
comments and recommendations for the Bryan Emery, Division of Scientific by the Commissioner or designee, who
proposed information collection should Advisors and Consultants, Center for is identified with consumer interests
be sent directly to the following: Office Biologics Evaluation and Research, and is recommended by either a
of Management and Budget, Paperwork Food and Drug Administration, 10993 consortium of consumer-oriented
Reduction Project, Email: OIRA_ New Hampshire Ave., Bldg. 71, Rm. organizations or other interested
SUBMISSION@OMB.EOP.GOV, Attn: 6132, Silver Spring, MD 20993–0002, persons. In addition to the voting
Desk Officer for the Administration for 240–402–8054, Bryan.emery@ members, the Committee may include
Children and Families. fda.hhs.gov. one non-voting member who is
Robert Sargis, SUPPLEMENTARY INFORMATION: Pursuant identified with industry interests.
Reports Clearance Officer. to 41 CFR 102–3.65 and approval by the The Commissioner or designee shall
[FR Doc. 2016–11791 Filed 5–18–16; 8:45 am] Department of Health and Human have the authority to select members of
BILLING CODE 4184–01–P
Services pursuant to 45 CFR part 11 and other scientific and technical FDA
by the General Services Administration, advisory committees (normally not to
FDA is announcing the renewal of the exceed 10 members) to serve
DEPARTMENT OF HEALTH AND Blood Products Advisory Committee. temporarily as voting members and to
HUMAN SERVICES The committee is a discretionary designate consultants to serve
Federal advisory committee established temporarily as voting members when:
Food and Drug Administration to provide advice to the Commissioner. (1) Expertise is required that is not
mstockstill on DSK3G9T082PROD with NOTICES
The Blood Products Advisory available among current voting standing
[Docket No. FDA–2016–N–0001] Committee advises the Commissioner or members of the Committee (when
Advisory Committee; Blood Products designee in discharging responsibilities additional voting members are added to
Advisory Committee; Renewal as they relate to helping to ensure safe the Committee to provide needed
and effective drugs for human use and, expertise, a quorum will be based on the
AGENCY: Food and Drug Administration, as required, any other product for which combined total of regular and added
HHS. FDA has regulatory responsibility. members), or (2) to comprise a quorum
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Document Created: 2018-02-07 15:01:20
Document Modified: 2018-02-07 15:01:20
| 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 | 81 FR 31641 |
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