Tribal Consultation Meeting, 7608-7609 [2015-02859]
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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
https://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.
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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]
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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 https://
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:
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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 https://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]
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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
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AGENCY:
Food and Drug Administration,
HHS.
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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
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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:
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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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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 https://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