Submission for OMB Review; Comment Request, 14670-14671 [2011-6068]
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14670
Federal Register / Vol. 76, No. 52 / Thursday, March 17, 2011 / Notices
Federal Register (FR) 6435 (February
20, 1996), and OMB guidelines
pertaining to computer matching at 54
FR 25818 (June 19, 1989).
Prior to 1991, CHAMPUS entitlement
terminated when any individual became
eligible for Medicare Part A on a nonpremium basis. The National Defense
Authorization Act(s) (NDAA) for Fiscal
Years (FY) 1992 and 1993 (Pub. L. 102–
190) § 704, provide for reinstatement of
CHAMPUS as second payer for
beneficiaries entitled to Medicare on the
basis of disability/End Stage Renal
Disease (ESRD) only if they also enroll
in Part B.
This agreement implements the
information matching provisions of the
NDAA, FY 2001 (Pub. L. 106–398)
Sections 711 and 712; the NDAA, FY
1993 (Pub. L. 102–484) Section 705; and
the NDAA, FY 1992 (Pub. L. 102–190)
Sections 704 and 713.
Section 732 of the FY 1996 NDAA
(Pub. L. 104–106), directed the
administering Secretaries to develop a
mechanism for notifying beneficiaries of
their ineligibility for CHAMPUS when
loss of eligibility is due to disability
status.
srobinson on DSKHWCL6B1PROD with NOTICES
PURPOSE (S) OF THE MATCHING PROGRAM:
The purpose of this agreement is to
establish the conditions, safeguards and
procedures under which CMS will
disclose Medicare enrollment
information to the DoD, DMDC, DEERS,
and Health Affairs/TMA. The disclosure
by CMS will provide TMA with the
information necessary to determine if
Military Health System (MHS)
beneficiaries (other than dependents of
active duty personnel), who are
Medicare eligible, are eligible to receive
continued military health care benefits.
This disclosure will provide TMA with
the information necessary to meet the
Congressional mandate outlined in
legislative provisions in the NDAA
listed above.
Current law requires TMA to
discontinue military health care benefits
to MHS beneficiaries who are Medicare
eligible and under the age of 65 when
they become eligible for Medicare Part
A because of disability/ESRD unless
they are enrolled in Medicare Part B.
Current law also requires TMA to
provide health care and medical
benefits to MHS beneficiaries who are
Medicare eligible (commonly referred to
as the dual eligible population) over the
age of 65 who are enrolled in the
supplementary medical insurance
program under Part B of the Medicare
program. This CMA will combine both
groups of the MHS beneficiary
population described above into one
single database to more effectively carry
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out this matching program. In order for
TMA to meet the requirements of
current law, CMS agrees to disclose
certain Part A and Part B enrollment
data on this dual eligible population,
which will be used to determine a
beneficiary’s eligibility for care under
CHAMPUS/TRICARE. DEERS will
receive the results of the computer
match and provide the information to
TMA for use in its matching program.
This computer matching agreement
supersedes all existing data exchange
agreements between CMS and DMDC
applicable to the exchange of personal
data for purposes of disclosing
enrollment and eligibility information
for MHS beneficiaries who are Medicare
eligible.
CATEGORIES OF RECORDS AND INDIVIDUALS
COVERED BY THE MATCH:
DEERS will furnish CMS with an
electronic file on a monthly basis
extracted from the DEERS’ systems of
records containing social security
numbers (SSN) for all MHS beneficiaries
who may also be eligible for Medicare
benefits. CMS will match the DEERS
finder file against its ‘‘Medicare
Beneficiary Database’’ system of records
(System No. 09–70–0536), and will
validate the identification of the
beneficiary and provide the Health
Insurance Claim Number that matches
against the SSN and date of birth
provided by DEERS, and also provide
the Medicare Part A entitlement status
and Part B enrollment status of the
beneficiary. CMS’s data will help TMA
to determine a beneficiary’s eligibility
for continued care under TRICARE.
DEERS will receive the results of the
computer match and provide the
information provided to TMA for use in
its program.
DESCRIPTION OF RECORDS TO BE USED IN THE
MATCHING PROGRAM:
DoD will use the SOR identified as
DMDC 02 DoD, entitled ‘‘Defense
Enrollment Eligibility Reporting
System,’’ at 74 Federal Register (FR)
39657 (August 7, 2009). SSNs of DoD
beneficiaries will be released to CMS
pursuant to the routine use set forth in
the system notice, which provides that
data may be released to HHS ‘‘for
support of the DEERS enrollment
process and to identify individuals not
entitled to health care.’’
Identification and Medicare status of
DoD eligible beneficiaries will be
provided to TMA to implement the
statutory program. Therefore, eligibility
information may also be maintained in
the SOR identified as DHA 07, entitled
‘‘Military Health Information System
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Fmt 4703
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(MHIS),’’ at 71 FR 16127 (March 30,
2006).
The release of the data for CMS is
covered under the ‘‘Enrollment
Database,’’ System No. 09–70–0502
published in the Federal Register at 73
FR 10249 (February 26, 2008). Matched
data will be released to DEERS pursuant
to the routine use number 2 as set forth
in the system notice.
INCLUSIVE DATES OF THE MATCH:
The Matching Program shall become
effective no sooner than 40 days after
the report of the Matching Program is
sent to OMB and Congress, or 30 days
after publication in the Federal
Register, which ever is later. The
matching program will continue for 18
months from the effective date and may
be renewed for an additional 12 month
period as long as the statutory language
for the match exists and other
conditions are met.
[FR Doc. 2011–6273 Filed 3–16–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Affordable Care Act Tribal
Maternal, Infant, and Early Childhood
Home Visiting Program Needs
Assessment and Plan for Responding to
Identified Needs.
OMB No.: New Collection.
Description: Section 511(h)(2)(A) of
Title V of the Social Security Act, as
added by Section 2951 of the Patient
Protection and Affordable Care Act of
2010 (Pub. L. 111–148, Affordable Care
Act or ACA), authorizes the Secretary of
HHS 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 sets aside 3 percent of the
total ACA Maternal, Infant, and Early
Childhood Home Visiting Program
appropriation (authorized in Section
511(j)) for grants to Tribal entities and
requires that the Tribal grants, to the
greatest extent practicable, be consistent
with the requirements of the Maternal,
Infant, and Early Childhood Home
Visiting Program grants to States and
territories (authorized in Section
511(c)), and include conducting a needs
assessment and establishing
benchmarks.
The Administration for Children and
Families, Office of Child Care, in
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Federal Register / Vol. 76, No. 52 / Thursday, March 17, 2011 / Notices
collaboration with the Health Resources
and Services Administration, Maternal
and Child Health Bureau, recently
awarded grants for the Tribal Maternal,
Infant, and Early Childhood Home
Visiting Program (Tribal Home Visiting).
The Tribal Home Visiting grant awards
will support 5-year cooperative
agreements to conduct community
needs assessments, plan for and
implement high-quality, culturallyrelevant, evidence-based home visiting
programs in at-risk Tribal communities,
and participate in research and
evaluation activities to build the
knowledge base on home visiting among
Native populations.
In Phase 1 (Year 1) of the cooperative
agreement, grantees must (1) conduct a
comprehensive community needs
assessment and (2) develop a plan and
begin to build capacity to respond to
identified needs. Grantees will be
expected to submit the needs
assessment and plan for responding to
identified needs through an evidencebased home visiting program within
10 months of the Year 1 award date.
Grantees may engage in needs
assessment, planning, and capacitybuilding activities during Phase 1, but
will not fully implement their plan and/
or begin serving children and families
through high-quality, evidence-based
home visiting programs. Pending
successful Phase 1 activities and
submission (within 10 months of Year 1
award date) of a non-competing
continuation application that includes a
needs assessment and approvable plan
for responding to identified needs,
funds will be provided for Phase 2
(Implementation Phase, Years 2–5)
Respondents: Affordable Care Act
Tribal Maternal, Infant, andEarly
Childhood Home Visiting Year 1
Grantees.
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
Needs Assessment and Plan ..........................................................................
18
1
100
1,800
srobinson on DSKHWCL6B1PROD with NOTICES
Estimated Total Annual Burden
Hours: 1,800.
Additional Information:
Copies of the proposed collection may
be obtained by writing to the
Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. All requests should be
identified by the title of the information
collection. E-mail address:
infocollection@acf.hhs.gov.
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, Fax: 202–395–7285,
E-mail:
OIRA_SUBMISSION@OMB.EOP.GOV,
Attn: Desk Officer for the
Administration for Children and
Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2011–6068 Filed 3–16–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–E–0405]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; ISTODAX
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
ISTODAX and is publishing this notice
of that determination as required by
law. FDA has made the determination
because of the submission of an
application to the Director of Patents
and Trademarks, Department of
Commerce, for the extension of a patent
which claims that human drug product.
ADDRESSES: Submit electronic
comments to https://
www.regulations.gov. Submit written
petitions along with three copies and
written comments to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
rm. 6222, Silver Spring, MD 20993–
0002, 301–796–3602.
SUPPLEMENTARY INFORMATION: The Drug
Price Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
and the Generic Animal Drug and Patent
SUMMARY:
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Frm 00025
Fmt 4703
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Term Restoration Act (Pub. L. 100–670)
generally provide that a patent may be
extended for a period of up to 5 years
so long as the patented item (human
drug product, animal drug product,
medical device, food additive, or color
additive) was subject to regulatory
review by FDA before the item was
marketed. Under these acts, a product’s
regulatory review period forms the basis
for determining the amount of extension
an applicant may receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For human drug
products, the testing phase begins when
the exemption to permit the clinical
investigations of the drug becomes
effective and runs until the approval
phase begins. The approval phase starts
with the initial submission of an
application to market the human drug
product and continues until FDA grants
permission to market the drug product.
Although only a portion of a regulatory
review period may count toward the
actual amount of extension that the
Director of Patents and Trademarks may
award (for example, half the testing
phase must be subtracted as well as any
time that may have occurred before the
patent was issued), FDA’s determination
of the length of a regulatory review
period for a human drug product will
include all of the testing phase and
approval phase as specified in 35 U.S.C.
156(g)(1)(B).
FDA recently approved for marketing
the human drug product ISTODAX
(romidepsin). ISTODAX is indicated for
treatment of cutaneous T-cell lymphoma
in patients who have received at least
one prior systemic therapy. Subsequent
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[Federal Register Volume 76, Number 52 (Thursday, March 17, 2011)]
[Notices]
[Pages 14670-14671]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-6068]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Comment Request
Title: Affordable Care Act Tribal Maternal, Infant, and Early
Childhood Home Visiting Program Needs Assessment and Plan for
Responding to Identified Needs.
OMB No.: New Collection.
Description: Section 511(h)(2)(A) of Title V of the Social Security
Act, as added by Section 2951 of the Patient Protection and Affordable
Care Act of 2010 (Pub. L. 111-148, Affordable Care Act or ACA),
authorizes the Secretary of HHS 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 sets aside 3 percent of the total ACA Maternal, Infant, and
Early Childhood Home Visiting Program appropriation (authorized in
Section 511(j)) for grants to Tribal entities and requires that the
Tribal grants, to the greatest extent practicable, be consistent with
the requirements of the Maternal, Infant, and Early Childhood Home
Visiting Program grants to States and territories (authorized in
Section 511(c)), and include conducting a needs assessment and
establishing benchmarks.
The Administration for Children and Families, Office of Child Care,
in
[[Page 14671]]
collaboration with the Health Resources and Services Administration,
Maternal and Child Health Bureau, recently awarded grants for the
Tribal Maternal, Infant, and Early Childhood Home Visiting Program
(Tribal Home Visiting). The Tribal Home Visiting grant awards will
support 5-year cooperative agreements to conduct community needs
assessments, plan for and implement high-quality, culturally-relevant,
evidence-based home visiting programs in at-risk Tribal communities,
and participate in research and evaluation activities to build the
knowledge base on home visiting among Native populations.
In Phase 1 (Year 1) of the cooperative agreement, grantees must (1)
conduct a comprehensive community needs assessment and (2) develop a
plan and begin to build capacity to respond to identified needs.
Grantees will be expected to submit the needs assessment and plan for
responding to identified needs through an evidence-based home visiting
program within 10 months of the Year 1 award date. Grantees may engage
in needs assessment, planning, and capacity-building activities during
Phase 1, but will not fully implement their plan and/or begin serving
children and families through high-quality, evidence-based home
visiting programs. Pending successful Phase 1 activities and submission
(within 10 months of Year 1 award date) of a non-competing continuation
application that includes a needs assessment and approvable plan for
responding to identified needs, funds will be provided for Phase 2
(Implementation Phase, Years 2-5)
Respondents: Affordable Care Act Tribal Maternal, Infant, andEarly
Childhood Home Visiting Year 1 Grantees.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Needs Assessment and Plan................... 18 1 100 1,800
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 1,800.
Additional Information:
Copies of the proposed collection may be obtained by writing to the
Administration for Children and Families, Office of Administration,
Office of Information Services, 370 L'Enfant Promenade, SW.,
Washington, DC 20447, Attn: ACF Reports Clearance Officer. All requests
should be identified by the title of the information collection. E-mail
address: infocollection@acf.hhs.gov.
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, Fax: 202-395-
7285, E-mail: OIRA_SUBMISSION@OMB.EOP.GOV, Attn: Desk Officer for the
Administration for Children and Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2011-6068 Filed 3-16-11; 8:45 am]
BILLING CODE 4184-01-P
