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. 

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 

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 

(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] 

BILLING CODE P 

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 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 76, No. 52 / Thursday, March 17, 2011 / Notices 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, 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 

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 

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. 

SUMMARY: 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 http:// 

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 

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 


srobinson on DSKHWCL6B1PROD with NOTICES