Tribal Consultation Meeting, 7608-7609 [2015-02859]

Download as PDF 7608 Federal Register / Vol. 80, No. 28 / Wednesday, February 11, 2015 / Notices Submission’’ or ‘‘More Search Options’’ to find the information collection document(s) that are accepting comments. 2. By regular mail. You may mail written comments to the following address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: Document Identifier/OMB Control Number lll, Room C4–26– 05, 7500 Security Boulevard, Baltimore, Maryland 21244–1850. To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following: 1. Access CMS’ Web site address at http://www.cms.hhs.gov/ PaperworkReductionActof1995. 2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to Paperwork@cms.hhs.gov. 3. Call the Reports Clearance Office at (410) 786–1326. FOR FURTHER INFORMATION CONTACT: Reports Clearance Office at (410) 786– 1326. SUPPLEMENTARY INFORMATION: Contents This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection’s supporting statement and associated materials (see ADDRESSES). tkelley on DSK3SPTVN1PROD with NOTICES CMS–10433 Initial Plan Data Collection To Support Qualified Health Plan (QHP) Certification and Other Financial Management and Exchange Operations Under the PRA (44 U.S.C. 3501– 3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term ‘‘collection of information’’ is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice. VerDate Sep<11>2014 17:07 Feb 10, 2015 Jkt 235001 Information Collection 1. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Initial Plan Data Collection to Support Qualified Health Plan (QHP) Certification and Other Financial Management and Exchange Operations; Use: As required by the CMS–9989–F, Patient Protection and Affordable Care Act; Establishment of Exchanges and Qualified Health Plans; Exchange Standards for Employers (77 FR 18310) (Exchange Establishment Rule), each Exchange must assume responsibilities related to the certification and offering of Qualified Health Plans (QHPs). In addition to data collection for the certification of QHPs, the reinsurance and risk adjustment programs outlined by the Affordable Care Act, detailed in 45 CFR part 153, as established by CMS–9975–F, Patient Protection and Affordable Care Act; Standards for Reinsurance, Risk Corridors, and Risk Adjustment (77 FR 17220), have general information reporting requirements that apply to issuers, group health plans, third party administrators, and plan offerings outside of the Exchanges. Subsequent regulations for these programs including the final HHS Notice of Benefit and Payment Parameters for 2014 and the Program Integrity: Exchange, Premium Stabilization Programs, and Market Standards; Amendments to the HHS Notice of Benefit and Payment Parameters for 2014, and the final HHS Notice of Benefit and Payment Parameters for 2015 provide further reporting requirements. Form Number: CMS–10433 (OMB control number 0938–1187); Frequency: Once; Affected Public: Individuals and households, private sector—business or other forprofits and not-for-profit institutions, State, Local or Tribal Governments; Number of Respondents: 900; Total Annual Responses: 900; Total Annual Hours: 150. (For policy questions regarding this collection contact Jaya Ghildiyal at 301–492–5149.) Dated: February 6, 2015. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2015–02852 Filed 2–10–15; 8:45 am] BILLING CODE 4120–01–P PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Tribal Consultation Meeting Office of Head Start (OHS), Administration for Children and Families, HHS. ACTION: Notice of meeting. AGENCY: Pursuant to the Improving Head Start for School Readiness Act of 2007, Public Law 110–134, notice is hereby given of one 1-day Tribal Consultation Session to be held between the Department of Health and Human Services, Administration for Children and Families, Office of Head Start leadership and the leadership of Tribal Governments operating Head Start (including Early Head Start) programs. The purpose of this Consultation Session is to discuss ways to better meet the needs of American Indian and Alaska Native children and their families, taking into consideration funding allocations, distribution formulas, and other issues affecting the delivery of Head Start services in their geographic locations [42 U.S.C. 9835, Section 640(l)(4)]. DATES: March 16, 2015, from 1:00 p.m. to 5:00 p.m. Location: Southwest Consortium of Indian Head Start, Native American Child and Family Conference, Hotel Albuquerque at Old Town, 800 Rio Grande Boulevard Northwest, Albuquerque, New Mexico 87104. FOR FURTHER INFORMATION CONTACT: Robert Bialas, Regional Program Manager, Region XI, Office of Head Start, email Robert.Bialas@acf.hhs.gov or phone (202) 205–9497. Additional information and online meeting registration is available at http:// eclkc.ohs.acf.hhs.gov/hslc/hs/calendar/ tc2015. SUPPLEMENTARY INFORMATION: The Department of Health and Human Services (HHS) announces an Office of Head Start (OHS) Tribal Consultation for leaders of Tribal Governments operating Head Start and Early Head Start programs. The agenda for the scheduled OHS Tribal Consultation in Albuquerque, New Mexico, will be organized around the statutory purposes of Head Start Tribal Consultations related to meeting the needs of American Indian/Alaska Native children and families, taking into consideration funding allocations, distribution formulas, and other issues affecting the delivery of Head Start services in their geographic locations. In SUMMARY: E:\FR\FM\11FEN1.SGM 11FEN1 Federal Register / Vol. 80, No. 28 / Wednesday, February 11, 2015 / Notices addition, OHS will share actions taken and in progress to address the issues and concerns raised in 2014 OHS Tribal Consultations. The Consultation Session will be conducted with elected or appointed leaders of Tribal Governments and their designated representatives [42 U.S.C. 9835, Section 640(l)(4)(A)]. Designees must have a letter from the Tribal Government authorizing them to represent the tribe prior to the Consultation Session. Other representatives of tribal organizations and Native nonprofit organizations are welcome to attend as observers. A detailed report of the Consultation Session will be prepared and made available within 45 days of the Consultation Session to all Tribal Governments receiving funds for Head Start and Early Head Start programs. Tribes wishing to submit written testimony for the report should send testimony to Robert Bialas at Robert.Bialas@acf.hhs.gov either prior to the Consultation Session or within 30 days after the meeting. Oral testimony and comments from the Consultation Session will be summarized in each report without attribution, along with topics of concern and recommendations. OHS has sent hotel and logistical information for the New Mexico Consultation Session to tribal leaders via email and posted information on the Early Childhood Learning and Knowledge Center Web site at http://eclkc.ohs.acf.hhs.gov/hslc/ hs/calendar/tc2015. Dated: February 6, 2015. Linda K. Smith, Deputy Assistant Secretary, Early Childhood Development. [FR Doc. 2015–02859 Filed 2–10–15; 8:45 am] BILLING CODE 4184–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–1031] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration Recall Regulations tkelley on DSK3SPTVN1PROD with NOTICES AGENCY: Food and Drug Administration, HHS. VerDate Sep<11>2014 17:07 Feb 10, 2015 Jkt 235001 ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by March 13, 2015. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–7285, or emailed to oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0249. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUMMARY: FDA Recall Regulation—21 CFR Part 7 (OMB Control Number 0910–0249)— Extension Section 701 of the Federal Food, Drug, and Cosmetic Act charges the Secretary of Health and Human Services, through FDA, with the responsibility of assuring recalls (21 U.S.C. 371, Regulations and Hearings, and 21 CFR part 7, Enforcement Policy, Subpart C, Recalls (Including Product Corrections)— Guidance on Policy, Procedures, and Industry Responsibilities) which pertain to the recall regulations and provide guidance to manufacturers on recall responsibilities. The guidelines apply to all FDA-regulated products (i.e., food, including animal feed; drugs, including animal drugs; medical devices, including in vitro diagnostic products; cosmetics; biological products intended for human use; and tobacco). These responsibilities include providing FDA with complete details of the recall including reason(s) for the PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 7609 removal or correction, risk evaluation, quantity produced, distribution information, the firm’s recall strategy, a copy of any recall communication(s), and a contact official (§ 7.46 (21 CFR 7.46)); notifying direct accounts of the recall, providing guidance regarding further distribution, giving instructions as to what to do with the product, providing recipients with a ready means of reporting to the recalling firm (§ 7.49); and submitting periodic status reports so that FDA may assess the progress of the recall. Status report information may be determined by, among other things, evaluation return reply cards, effectiveness checks and product returns (§ 7.53); and providing the opportunity for a firm to request in writing that FDA terminate the recall (§ 7.55(b)). A search of FDA’s database was performed to determine the number of recalls that took place during fiscal years 2011 to 2013. The resulting number of total recalls (11,403) from this database search were then averaged over the 3 years, and the resulting per year average of recalls (3,801) are used in estimating the current annual reporting burden for this report. The resulting number of total terminations (11,403) from this database search were then averaged over the 3 years, and the resulting per year average of terminations (3,801) are used in estimating the current annual reporting burden for this report. In the Federal Register of August 4, 2014 (79 FR 45197), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the total annual industry burden to collect and provide the previous information to be 721,886 burden hours. The following is a summary of the estimated annual burden hours for recalling firms (manufacturers, processors, and distributors) to comply with the voluntary reporting requirements of FDA’s recall regulations, recognizing that there may be a vast difference in the information collection and reporting time involved in different recalls of FDA’s regulated products. FDA estimates the burden of this collection of information as follows: E:\FR\FM\11FEN1.SGM 11FEN1

Agencies

[Federal Register Volume 80, Number 28 (Wednesday, February 11, 2015)]
[Notices]
[Pages 7608-7609]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-02859]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Administration for Children and Families


Tribal Consultation Meeting

AGENCY: Office of Head Start (OHS), Administration for Children and 
Families, HHS.

ACTION: Notice of meeting.

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SUMMARY: Pursuant to the Improving Head Start for School Readiness Act 
of 2007, Public Law 110-134, notice is hereby given of one 1-day Tribal 
Consultation Session to be held between the Department of Health and 
Human Services, Administration for Children and Families, Office of 
Head Start leadership and the leadership of Tribal Governments 
operating Head Start (including Early Head Start) programs. The purpose 
of this Consultation Session is to discuss ways to better meet the 
needs of American Indian and Alaska Native children and their families, 
taking into consideration funding allocations, distribution formulas, 
and other issues affecting the delivery of Head Start services in their 
geographic locations [42 U.S.C. 9835, Section 640(l)(4)].

DATES: March 16, 2015, from 1:00 p.m. to 5:00 p.m.
    Location: Southwest Consortium of Indian Head Start, Native 
American Child and Family Conference, Hotel Albuquerque at Old Town, 
800 Rio Grande Boulevard Northwest, Albuquerque, New Mexico 87104.

FOR FURTHER INFORMATION CONTACT: Robert Bialas, Regional Program 
Manager, Region XI, Office of Head Start, email 
Robert.Bialas@acf.hhs.gov or phone (202) 205-9497. Additional 
information and online meeting registration is available at http://eclkc.ohs.acf.hhs.gov/hslc/hs/calendar/tc2015.

SUPPLEMENTARY INFORMATION: The Department of Health and Human Services 
(HHS) announces an Office of Head Start (OHS) Tribal Consultation for 
leaders of Tribal Governments operating Head Start and Early Head Start 
programs.
    The agenda for the scheduled OHS Tribal Consultation in 
Albuquerque, New Mexico, will be organized around the statutory 
purposes of Head Start Tribal Consultations related to meeting the 
needs of American Indian/Alaska Native children and families, taking 
into consideration funding allocations, distribution formulas, and 
other issues affecting the delivery of Head Start services in their 
geographic locations. In

[[Page 7609]]

addition, OHS will share actions taken and in progress to address the 
issues and concerns raised in 2014 OHS Tribal Consultations.
    The Consultation Session will be conducted with elected or 
appointed leaders of Tribal Governments and their designated 
representatives [42 U.S.C. 9835, Section 640(l)(4)(A)]. Designees must 
have a letter from the Tribal Government authorizing them to represent 
the tribe prior to the Consultation Session. Other representatives of 
tribal organizations and Native nonprofit organizations are welcome to 
attend as observers.
    A detailed report of the Consultation Session will be prepared and 
made available within 45 days of the Consultation Session to all Tribal 
Governments receiving funds for Head Start and Early Head Start 
programs. Tribes wishing to submit written testimony for the report 
should send testimony to Robert Bialas at Robert.Bialas@acf.hhs.gov 
either prior to the Consultation Session or within 30 days after the 
meeting.
    Oral testimony and comments from the Consultation Session will be 
summarized in each report without attribution, along with topics of 
concern and recommendations. OHS has sent hotel and logistical 
information for the New Mexico Consultation Session to tribal leaders 
via email and posted information on the Early Childhood Learning and 
Knowledge Center Web site at http://eclkc.ohs.acf.hhs.gov/hslc/hs/calendar/tc2015.

    Dated: February 6, 2015.
Linda K. Smith,
Deputy Assistant Secretary, Early Childhood Development.
[FR Doc. 2015-02859 Filed 2-10-15; 8:45 am]
BILLING CODE 4184-01-P