23938 Federal Register / Vol. 78, No. 78 / Tuesday, April 23, 2013 / Notices 

Reopening, under the Regulations and Guidance 

section at www.errp.gov. 

4See footnotes 2 and 3. However, as discussed 

above, a sponsor that knows or should know, before 

or on April 30, 2013, of any data inaccuracy 

contained in a reimbursement request for a plan 

year for which a reimbursement determination was 

made, must submit a reimbursement request with 

corrected data by July 31, 2013, rather than by no 

later than the end of the next calendar quarter after 

the sponsor knows or should know of the data 

inaccuracy. 

5See footnote 3. 

Because the process for submitting 

corrections to data inaccuracies 

leverages the process for submitting 

reimbursement requests, we have 

concluded that plan sponsors will no 

longer be required to submit corrections 

to data inaccuracies after July 31, 2013, 

that is, the last day upon which a plan 

sponsor may submit an ERRP 

reimbursement request. This means that 

plan sponsors that know or should 

know, before or on April 30, 2013, of 

any data inaccuracy contained in a 

reimbursement request for a plan year 

for which a reimbursement 

determination was made, must submit 

corrections to the data inaccuracy in a 

manner consistent with the ERRP 

regulations and guidance.4 A plan 

sponsor that does not know with 

certainty its final amount of price 

concessions for a given plan year, but 

knows or should know, as of April 30, 

2013, of estimates that vary from 

previously reported price concession 

amounts for that plan year, must 

consider those previous amounts to 

constitute data inaccuracies, and 

therefore is required to report and 

correct that data by July 31, 2013. 

E. Last Day Plan Sponsors May Submit 

a Request To Reopen and Revise an 

Adverse Reimbursement Determination 

The ERRP regulations at 45 CFR 

149.610 permit the Secretary to reopen 

and revise a reimbursement 

determination upon the Secretary’s own 

motion or upon the request of a plan 

sponsor. The regulations, as well as 

guidance published on www.errp.gov,5

set forth the process by which a plan 

sponsor may request a reopening, as 

well as other information related to 

reopenings. In preparation for the ERRP 

sunset date, the last day upon which a 

plan sponsor may submit an ERRP 

reopening request is December 31, 2013. 

III. Collection of Information 

Requirements 

Under the Paperwork Reduction Act 

of 1995, we are required to provide 60- 

day notice in the Federal Register and 

solicit public comment before a 

collection of information requirement is 

submitted to the Office of Management 

and Budget (OMB) for review and 

approval. The information collection 

requirements associated with the ERRP 

are currently approved under OMB 

control number 0938–1087, with an 

expiration date of September 30, 2014. 

This document does not impose any 

new information collection and 

recordkeeping requirements beyond the 

prior estimates in the supporting 

statement for the interim final rule, 

CMS–9995–IFC. Consequently, it need 

not be reviewed by the Office of 

Management and Budget under the 

authority of the Paperwork Reduction 

Act of 1995. 

Authority: Sections 1102(a)(l) of the 

Affordable Care Act (42 U.S.C. § 18002(a)(l) 

and(c)(4)). 

Dated: April 16, 2013. 

Marilyn Tavenner, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2013–09541 Filed 4–19–13; 11:15 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

Privacy Act of 1974; Report of a New 

Routine Use for Selected CMS 

Systems of Records 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), Department 

of Health and Human Services (HHS). 

ACTION: Altered Systems Notice, Adding 

a New Routine Use to Selected CMS 

Systems of Records. 

SUMMARY: In accordance with the 

requirements of the Privacy Act of 1974 

(5 U.S.C. 552a), CMS is adding a new 

routine use for emergency preparedness 

and response to eight CMS systems of 

records. The new routine use will 

authorize CMS to disclose beneficiaryidentifiable records to public health 

authorities and entities acting under a 

delegation of authority of a public 

health authority requesting such 

information for the purpose of 

identifying vulnerable individuals who 

may need health assistance in the event 

of an incident, emergency or disaster, 

and for purposes of planning and 

providing such assistance. Disclosures 

made pursuant to the new routine use 

will be limited to the minimum data 

necessary to carry out statutorilyauthorized public health-related 

emergency preparedness and response 

activities, as provided in Section 1106 

of the Social Security Act (42 U.S.C. 

1306) and the HIPAA Privacy Rule at 45 

CFR §§ 154.502, 164.512(b), 164.502(b) 

and 164.514(d)(3)(iii)(A). Requests and 

disclosures made pursuant to the 

routine use will be coordinated through 

HHS’ Office of the Assistant Secretary 

for Preparedness and Response (ASPR). 

The eight systems of records that will 

include the new routine use are: the 

National Claims History (NCH), System 

No. 09–70–0558; Medicare Integrated 

Data Repository (IDR), System No. 09– 

70–0571; Common Working Files 

(CWF), System No. 09–70–0526; 

Enrollment Database (EDB), System No. 

09–70–0502; Medicare Beneficiary 

Database (MBD), System No. 09–70– 

0536; Medicare Drug Data Processing 

System (DDPS), System No. 09–70– 

0553; Long Term Care-Minimum Data 

Set (MDS), System No. 09–70–0528; and 

Home Health Agency (HHA) Outcome 

and Assessment Information Set 

(OASIS), System No. 09–70–0522. 

DATES: Effective Date: The new routine 

use described in this notice will become 

effective without further notice 30 days 

after publication of this notice in the 

Federal Register, unless comments 

received on or before that date result in 

revisions to this notice. 

ADDRESSES: The public should send 

comments to: CMS Privacy Officer, 

Division of Privacy Policy, Privacy 

Policy and Compliance Group, Office of 

E-Health Standards & Services, Office of 

Enterprise Management, CMS, Room 

S2–24–25, 7500 Security Boulevard, 

Baltimore, Maryland 21244–1850. 

Comments received will be available for 

review at this location, by appointment, 

during regular business hours, Monday 

through Friday from 9:00 a.m.–3:00 

p.m., Eastern Time zone. 

FOR FURTHER INFORMATION CONTACT: 

Kristen P. Finne, Senior Program 

Analyst U.S. Department of Health and 

Human Services, Office of the Assistant 

Secretary for Preparedness and 

Response (ASPR), Office of Policy and 

Planning, Division of Health System 

Policy (HSP), Patriots Plaza, 375 E Street 

SW., Office 11–1701, Washington DC 

20024, Office telephone: 202–691–2013, 

Blackberry: 202–439–1140, Email: 

kristen.finne@hhs.gov. 

SUPPLEMENTARY INFORMATION: The new 

routine use will improve the ability of 

HHS’ Assistant Secretary for 

Preparedness and Response (ASPR), in 

partnership with HHS’ Centers for 

Medicare & Medicaid Services, to assist 

public health authorities and entities 

acting under a delegation of authority of 

a public health authority in identifying 

vulnerable individuals who may need 

health assistance prior to, during, and in 

the aftermath of an incident, emergency 

or disaster that poses an adverse health 

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Federal Register / Vol. 78, No. 78 / Tuesday, April 23, 2013 / Notices 23939 

and/or public health impact, and in 

planning and providing such assistance. 

Disclosing beneficiary-identifiable 

records for public health-related 

emergency preparedness and response 

purposes is a necessary and proper use 

of the information in the systems of 

records being modified; the new routine 

use is compatible with the health care 

purposes for which the information was 

collected in the CMS systems of records. 

Disclosure purposes could include 

emergency planning for outreach to atrisk populations and individuals during 

a public health emergency. For example, 

a public health agency could match the 

records with publicly available power 

outage data from another department or 

agency. In the event of a public health 

emergency that involves power outages, 

the public health agency would then be 

able to use the results of the matched 

data to identify individuals in the 

affected community who are dependent 

on energy for meeting their medical 

needs, for example individuals living in 

the community who are dependent on 

dialysis. The term ‘‘public health 

authority’’ and the concepts of ‘‘public 

health activity’’ and ‘‘minimum 

necessary’’ disclosures are defined in 

the HIPAA Privacy Rule at 45 CFR 

§§ 154.502, 164.512(b), 164.502(b) and 

164.514(d)(3)(iii)(A). 

For the reasons described above, the 

following routine use is added to the 

eight systems of records listed below: 

To disclose beneficiary-identifiable 

information to public health authorities, and 

those entities acting under a delegation of 

authority from a public health authority, 

when requesting such information to carry 

out statutorily-authorized public health 

activities pertaining to emergency 

preparedness and response. Disclosures 

under this routine use will be limited to 

‘‘public health authorities,’’ ‘‘public health 

activities,’’ and ‘‘minimum necessary data’’ 

as defined in the HIPAA Privacy Rule (45 

CFR §§ 154.502, 164.512(b), 164.502(b) and 

164.514(d)(3)(iii)(A)). 

1. National Claims History (NCH), 

System No. 09–70–0588, published at 

71 Federal Register (Fed. Reg.), 67137 

(November 20, 2006). 

2. Medicare Integrated Data 

Repository (IDR), System No. 09–70– 

0571, published at 71 Fed. Reg., 74915 

(December 13, 2006). 

3. Common Working Files (CWF), 

System No. 09–70–0526, published at 

71 Fed. Reg., 64955 (November 6, 2006). 

4. Enrollment Database (EDB), System 

No. 09–70–0502, published at 73 Fed. 

Reg., 10249 (February 26, 2008). 

5. Medicare Beneficiary Database 

(MBD), System No. 09–70–0536, 

published at 71 Fed. Reg., 70396 

(December 4, 2006). 

6. Medicare Drug Data Processing 

System (DDPS), System No. 09–70– 

0553, published at 73 Fed. Reg., 30943 

(May 29, 2008). 

7. Long Term Care (LTC)-Minimum 

Data Set (MDS), System No. 09–70– 

0528, published at 72 Fed. Reg., 12801 

(March 19, 2007). 

8. Home Health Agency (HHA) 

Outcome and Assessment Information 

Set (OASIS), System No. 09–70–0522, 

published at 72 Fed. Reg. 63906 

(November 13, 2007). 

Dated: April 11, 2013. 

Michelle Snyder, 

Deputy Chief Operating Officer, Centers for 

Medicare & Medicaid Services. 

[FR Doc. 2013–09511 Filed 4–22–13; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0176] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Experimental Study: Examination of 

Corrective Direct-to-Consumer 

Television Advertising 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Experimental Study: Examination of 

Corrective Direct-to-Consumer 

Television Advertising’’ has been 

approved by the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995. 

FOR FURTHER INFORMATION CONTACT: 

Daniel Gittleson, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

5156, daniel.gittleson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: On 

January 8, 2013, the Agency submitted 

a proposed collection of information 

entitled ‘‘Experimental Study: 

Examination of Corrective Direct-toConsumer Television Advertising’’ to 

OMB for review and clearance under 44 

U.S.C. 3507. An Agency may not 

conduct or sponsor, and a person is not 

required to respond to, a collection of 

information unless it displays a 

currently valid OMB control number. 

OMB has now approved the information 

collection and has assigned OMB 

control number 0910–0737. The 

approval expires on March 31, 2016. A 

copy of the supporting statement for this 

information collection is available on 

the Internet at http://www.reginfo.gov/ 

public/do/PRAMain. 

Dated: April 16, 2013. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2013–09482 Filed 4–22–13; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0477] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Investigational Device Exemptions 

Reports and Records 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Investigational Device Exemptions 

Reports and Records’’ has been 

approved by the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995. 

FOR FURTHER INFORMATION CONTACT: 

Daniel Gittleson, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

5156, daniel.gittleson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: On 

January 3, 2013, the Agency submitted 

a proposed collection of information 

entitled ‘‘Investigational Device 

Exemptions Reports and Records’’ to 

OMB for review and clearance under 44 

U.S.C. 3507. An Agency may not 

conduct or sponsor, and a person is not 

required to respond to, a collection of 

information unless it displays a 

currently valid OMB control number. 

OMB has now approved the information 

collection and has assigned OMB 

control number 0910–0078. The 

approval expires on March 31, 2016. A 

copy of the supporting statement for this 

information collection is available on 

the Internet at http://www.reginfo.gov/ 

public/do/PRAMain. 

Dated: April 15, 2013. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2013–09481 Filed 4–22–13; 8:45 am] 

BILLING CODE 4160–01–P 

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