Federal Register / Vol. 74, No. 195 / Friday, October 9, 2009 / Notices 52235 

Forms 

(if necessary) Type of respondent Number of respondents 

Number of responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

Total ........................................... ........................................................... ........................ ........................ ........................ 1,116 

Seleda Perryman, 

Paperwork Reduction Act Reports Clearance 

Officer, Office of the Secretary. 

[FR Doc. E9–24470 Filed 10–8–09; 8:45 am] 

BILLING CODE 4150–37–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier 0990–0346] 

Agency Information Collection 

Request; 60-Day Public Comment 

Request 

AGENCY: Office of the Secretary, HHS. 

In compliance with the requirement 

of section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995, the 

Office of the Secretary (OS), Department 

of Health and Human Services, is 

publishing the following summary of a 

proposed information collection request 

for public comment. Interested persons 

are invited to send comments regarding 

this burden estimate or any other aspect 

of this collection of information, 

including any of the following subjects: 

(1) The necessity and utility of the 

proposed information collection for the 

proper performance of the agency’s 

functions; (2) the accuracy of the 

estimated burden; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) the 

use of automated collection techniques 

or other forms of information 

technology to minimize the information 

collection burden. To obtain copies of 

the supporting statement and any 

related forms for the proposed 

paperwork collections referenced above, 

e-mail your request, including your 

address, phone number, OMB number, 

and OS document identifier, to 

Sherette.funncoleman@hhs.gov, or call 

the Reports Clearance Office on (202) 

690–6162. Written comments and 

recommendations for the proposed 

information collections must be directed 

to the OS Paperwork Clearance Officer 

at the above e-mail address within 60 

days. 

Proposed Project: HITECH Act Breach 

Notification—OMB No. 0990–0346– 

Extension—Office of Civil Rights. 

Abstract: The Health Information 

Technology for Economic and Clinical 

Health (HITECH) Act, Title XIII of 

Division A and Title IV of Division B of 

the American Recovery and 

Reinvestment Act of 2009 (ARRA) (Pub. 

L. 111–5) requires the Office for Civil 

Rights to collect information regarding 

breaches discovered by covered entities 

and their business associates under the 

Health Insurance Portability and 

Accountability Act of 1996 (HIPAA) 

Privacy Rule (45 C.F.R. Part 160 and 

Subparts A and E of Part 164). ARRA 

was enacted on February 17, 2009. The 

Department of Health and Human 

Services (HHS) issued interim final 

regulations on August 24, 2009 (74 FR 

42740), which became effective 

September 23, 2009, to require HIPAA 

covered entities and their business 

associates to provide notification in the 

case of breaches of unsecured protected 

health information. Section 164.404 of 

this interim final regulation requires 

HIPAA covered entities to notify 

affected individuals of a breach of their 

unsecured protected health information 

and, in some cases, to notify the media 

of such breaches pursuant to § 164.406. 

Section 164.408 requires covered 

entities to provide the Secretary with 

immediate notice of all breaches of 

unsecured protected health information 

involving more than 500 individuals. 

Additionally, the Act requires covered 

entities to provide the Secretary with an 

annual log of all breaches of unsecured 

protected health information that 

involve less than 500 individuals. 

Finally, business associates must notify 

the covered entity of any breaches that 

occur subject to § 164.410. 

Estimated Annualized Burden Table 

Type of respondent Number of 

respondents 

Average 

number of 

responses 

per respondent 

Average 

burden hours 

per response 

Total burden 

hours 

Individual Notice—Written and E-mail Notice (drafting, preparing, sending, 

and documenting notification) ...................................................................... 106 1 206 21,836 

500 or More Affected Individuals (investigating and documenting breach) .... 56 1 44 2,464 

Less than 500 Affected Individuals (investigating and documenting breach) 50 1 8 400 

Individual Notice—Substitute Notice (posting or publishing) ........................... 70 1 1 70 

Individual Notice—Substitute Notice (toll-free number) ................................... 70 1 3,438 240,660 

Media Notice .................................................................................................... 56 1 1 56 

Notice to Secretary (notice for breaches affecting 500 or more individuals 

and annual notice and maintenance of annual log) .................................... 106 1 140/60 247 

TOTAL ...................................................................................................... ........................ ........................ ........................ 265,733 

Seleda Perryman, 

Office of the Secretary, Paperwork Reduction 

Act Reports Clearance Officer. 

[FR Doc. E9–24471 Filed 10–8–09; 8:45 am] 

BILLING CODE 4153–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Findings of Research Misconduct 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: Notice is hereby given that 

the Office of Research Integrity (ORI) 

and the Assistant Secretary for Health 

have taken final action in the following 

case: 

Norma Couvertier, APT Foundation: 

Based on the report of an investigation 

conducted by the APT Foundation and 

additional analysis conducted by ORI in 

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52236 Federal Register / Vol. 74, No. 195 / Friday, October 9, 2009 / Notices 

its oversight review, ORI found that 

Norma Couvertier, former Research 

Assistant II, APT Foundation in New 

Haven, Connecticut, engaged in research 

misconduct in research supported by 

National Institute of Drug Abuse 

(NIDA), National Institutes of Health 

(NIH), award R37 DA015969. 

Specifically, ORI found that Ms. 

Couvertier engaged in research 

misconduct by falsifying and fabricating 

data that were reported on Participant 

Urine Monitoring and Breathalyzer 

Result Forms (CRFs) completed by the 

Respondent for thirty two (32) of the 

enrolled study participants in the 

computer Based Training in Cognitive 

Behavioral Therapy (CBT4CBT) research 

study. A total of 253 alcohol 

breathalyzer (BALS) results were 

recorded for the 32 participants as being 

0.000 indicating no alcohol detected, 

rather than the code 999 used when no 

breathalyzer test was done. 

ORI also found that Ms. Couvetier, on 

253 occasions, with 32 different study 

participants, falsified alcohol 

breathalyzer test results and knowingly 

and consistently entered a false negative 

test (indicated by 0.000) rather than 

identifying the result as a missing data 

collection (indicated by code 999). 

ORI acknowledges Ms. Couvetier’s 

verbal admissions and willingness to 

cooperate and assist during the APT 

Foundation’s investigation. 

Ms. Couvertier has entered into a 

Voluntary Settlement Agreement in 

which she has voluntarily agreed, for a 

period of three (3) years, beginning on 

September 18, 2009: 

(1) To exclude herself from serving in 

any advisory capacity to the U.S. Public 

Health Service (PHS), including but not 

limited to service on any PHS advisory 

committee, board, and/or peer review 

committee, or as a consultant; 

(2) that any institution that submits an 

application for PHS support for a 

research project on which the 

Respondent’s participation is proposed 

or that uses her in any capacity on PHSsupported research or that submits a 

report of PHS-funded research in which 

she is involved must concurrently 

submit a plan for supervision of her 

duties to ORI. The supervisory plan 

must be designed to ensure the integrity 

of her research contribution. 

Respondent agreed that she will not 

participate in any PHS-supported 

research until such a supervisory plan is 

approved by ORI. 

FOR FURTHER INFORMATION CONTACT: 

Director, Division of Investigative 

Oversight, Office of Research Integrity, 

1101 Wootton Parkway, Suite 750, 

Rockville, MD 20852. (240) 453–8800. 

John Dahlberg, 

Director, Division of Investigative Oversight, 

Office of Research Integrity. 

[FR Doc. E9–24392 Filed 10–8–09; 8:45 am] 

BILLING CODE 4150–31–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier CMS–10142, CMS–R– 

262, CMS–10300, CMS–10298 and CMS– 

10294] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services. 

In compliance with the requirement 

of section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995, the 

Centers for Medicare & Medicaid 

Services (CMS) is publishing the 

following summary of proposed 

collections for public comment. 

Interested persons are invited to send 

comments regarding this burden 

estimate or any other aspect of this 

collection of information, including any 

of the following subjects: (1) The 

necessity and utility of the proposed 

information collection for the proper 

performance of the agency’s functions; 

(2) the accuracy of the estimated 

burden; (3) ways to enhance the quality, 

utility, and clarity of the information to 

be collected; and (4) the use of 

automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

1. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: CY 2011 Bid 

Pricing Tool (BPT) for Medicare 

Advantage (MA) Plans and Prescription 

Drug Plans (PDP); Use: Under the 

Medicare Prescription Drug, 

Improvement, and Modernization Act of 

2003 (MMA), and implementing 

regulations at 42 CFR, Medicare 

Advantage organizations (MAO) and 

Prescription Drug Plans are required to 

submit an actuarial pricing ‘‘bid’’ for 

each plan offered to Medicare 

beneficiaries for approval CMS. 

MAOs and PDPs use the Bid Pricing 

Tool (BPT) software to develop their 

actuarial pricing bid. The information 

provided in the BPT is the basis for the 

plan’s enrollee premiums and CMS 

payments for each contract year. The 

tool collects data such as medical 

expense development (from claims data 

and/or manual rating), administrative 

expenses, profit levels, and projected 

plan enrollment information. By statute, 

completed BPTs are due to CMS by the 

first Monday of June each year. 

CMS reviews and analyzes the 

information provided on the Bid Pricing 

Tool. Ultimately, CMS decides whether 

to approve the plan pricing (i.e., 

payment and premium) proposed by 

each organization. Refer to the 

supporting document attachment ‘‘C’’ 

for a list of changes. Form Number: 

CMS–10142 (OMB#: 0938–0944); 

Frequency: Reporting—Yearly; Affected 

Public: Business or other for-profit and 

not-for-profit institutions; Number of 

Respondents: 550; Total Annual 

Responses: 6,050; Total Annual Hours: 

42,350. (For policy questions regarding 

this collection contact Diane Spitalnic at 

410–786–5745. For all other issues call 

410–786–1326.) 

2. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: CY 2011 Plan 

Benefit Package (PBP) Software and 

Formulary Submission Use: Under the 

Medicare Modernization Act (MMA), 

Medicare Advantage (MA) and 

Prescription Drug Plan (PDP) 

organizations are required to submit 

plan benefit packages for all Medicare 

beneficiaries residing in their service 

area. The plan benefit package 

submission consists of the PBP software, 

formulary file, and supporting 

documentation, as necessary. MA and 

PDP organizations use the PBP software 

to describe their organization’s plan 

benefit packages, including information 

on premiums, cost sharing, 

authorization rules, and supplemental 

benefits. They also generate a formulary 

to describe their list of drugs, including 

information on prior authorization, step 

therapy, tiering, and quantity limits. 

Additionally, CMS uses the PBP and 

formulary data to review and approve 

the plan benefit packages proposed by 

each MA and PDP organization. 

CMS requires that MA and PDP 

organizations submit a completed PBP 

and formulary as part of the annual 

bidding process. During this process, 

organizations prepare their proposed 

plan benefit packages for the upcoming 

contract year and submit them to CMS 

for review and approval. Based on 

operational changes and policy 

clarifications to the Medicare program 

and continued input and feedback by 

the industry, CMS has made the 

necessary changes to the plan benefit 

package submission. Refer to the 

supporting document ‘‘Appendix B’’ for 

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