Federal Register / Vol. 74, No. 198 / Thursday, October 15, 2009 / Notices 52965 

and other entities as part of the 

settlement of Federal health care 

program fraud investigations arising 

under civil and administrative false 

claims statutes. These obligations are set 

forth in a CIA. A provider or an entity 

consents to a CIA in conjunction with 

a civil or administrative settlement and 

in exchange for OIG’s agreement not to 

seek to exclude that health care provider 

or entity from participation in Medicare, 

Medicaid, and other Federal health care 

programs under 42 U.S.C. 1320a–7. 

False claims submitted in violation of 

the False Claims Act or Civil Monetary 

Penalties Law give rise to OIG’s 

permissive exclusion authority under 42 

U.S.C. 1320a–7(b)(7). 

The typical term of a CIA is 5 years. 

CIAs seek to ensure the integrity of 

Federal health care program claims 

submitted by the provider. CIAs 

generally include requirements to, 

among other things: (1) Hire a 

compliance officer; (2) appoint a 

compliance committee; (3) develop 

written standards and policies; (4) 

implement a comprehensive employee 

training program; (5) establish a 

confidential disclosure program; (6) 

restrict employment of ineligible 

persons; (7) report overpayments, 

reportable events, and ongoing 

investigations/legal proceedings; and (8) 

provide an implementation report and 

annual reports to OIG on the status of 

the entity’s compliance activities. 

When resolving cases that involve 

quality-of-care allegations, OIG often 

requires health care providers to enter 

into quality-of-care CIAs. OIG may enter 

into quality-of-care CIAs with many 

different types of health care providers, 

including, but not limited to, skilled 

nursing facilities, assisted-living 

facilities, psychiatric facilities, 

intermediate care facilities for the 

mentally retarded, hospitals, physician 

practices, dental practices, and 

management companies. Under these 

quality-of-care CIAs, health care 

providers agree to compliance 

obligations that include quality 

assurance and improvement. One such 

obligation is to retain an appropriately 

qualified monitor, which is appointed 

by OIG after consultation with the 

health care provider. The monitor 

selected contracts directly with the 

provider. The monitor does not enter 

into any contractual relationship with 

OIG or act as an agent for OIG. 

The monitor typically is responsible 

for assessing the effectiveness, 

reliability, and thoroughness of the 

provider’s: (1) Internal quality control 

systems; (2) response to quality-of-care 

issues; (3) development and 

implementation of corrective action 

plans and the timeliness of such actions; 

(4) proactive steps to ensure that each 

patient receives care in accordance with 

basic care, treatment, and protectionfrom-harm standards; the governing 

regulations; and the policies and 

procedures required to be adopted 

under the CIA; and (5) in residential 

settings, compliance with staffing 

requirements. In making these 

assessments, the monitor conducts site 

visits, analyzes available data, observes 

facility and corporate-level committee 

meetings, and reviews relevant 

documents. The monitor submits 

regular written reports to the provider 

and OIG. 

Responses to This Notice 

OIG is interested in hearing from 

organizations that believe they have the 

capability to be a monitor for quality-ofcare CIAs. Please include in any 

response to this notice the following: 

1. The name of the organization; 

2. The size and location(s) of the 

organization; 

3. The qualifications of the 

organization to serve as a monitor for 

quality-of-care CIAs; 

4. The organization’s capacity to 

monitor large providers with locations 

in multiple States; 

5. The organization’s clinical 

experience and expertise; 

6. The organization’s experience with 

quality assessment, assurance, and 

improvement; 

7. The organization’s prior monitoring 

experience, including, but not limited 

to, systems reviews and auditing; and 

8. An indication of whether the 

organization has any current or prior 

(within the last 5 years) Federal 

Government contracts or is on any 

General Services Administration or HHS 

list of approved contractors. 

OIG will review each response 

submitted to this notice to assess 

whether the organization may be 

appropriate to serve as a monitor for 

quality-of-care CIAs. The assessment 

will not be for the purpose of making 

any definitive determination regarding 

whether a particular organization is 

qualified to be a monitor or creating a 

list of pre-approved monitors. Factors 

that OIG considers when assessing 

whether an organization may be an 

appropriate monitor for a particular CIA 

include, among other things, the 

organization’s clinical expertise, 

capacity to handle a particular 

monitoring relationship, quality 

monitoring experience, geographic 

location, and independence and 

objectivity. Each provider and qualityof-care CIA is unique. Accordingly, the 

selection of an appropriate monitor for 

any given quality-of-care CIA requires 

consideration of unique and 

individualized factors. In order to select 

an appropriate monitor for any 

individual quality-of-care CIA, OIG may 

contact an organization that submitted 

information in response to this notice to 

request additional information. In 

selecting a monitor, OIG will not be 

limited to organizations that submitted 

information in response to this notice. 

Any organization submitting 

information in response to this notice 

should identify any information that it 

believes is trade secret, or commercial 

or financial information, and privileged 

or confidential under exemption four of 

the Freedom of Information Act (FOIA). 

Consistent with the HHS FOIA 

regulations, set forth in 45 CFR Part 5, 

when OIG receives a request for such 

records and OIG determines that OIG 

may be required to disclose them, OIG 

will make reasonable efforts to notify 

the organization about these facts. 

Daniel R. Levinson, 

Inspector General. 

[FR Doc. E9–24715 Filed 10–14–09; 8:45 am] 

BILLING CODE 4152–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0483] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Medical Device 

User Fee Cover Sheet; Form FDA 3601 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

Form FDA 3601 entitled ‘‘Medical 

Device User Fee Cover Sheet,’’ which 

must be submitted along with certain 

medical device product applications, 

supplements, and fee payment of those 

applications. 

mstockstill on DSKH9S0YB1PROD with NOTICES

52966 Federal Register / Vol. 74, No. 198 / Thursday, October 15, 2009 / Notices 

1PDP means product development protocol; PMR 

means postmarketing requirements; and BLA means 

biologics license applications. 

DATES: Submit written or electronic 

comments on the collection of 

information by December 14, 2009. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley Jr., Office of Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3793. 

SUPPLEMENTARY INFORMATION: 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. 

‘‘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 (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Medical Device User Fee Cover Sheet; 

Form FDA 3601 (OMB Control Number 

0910–0511)–Extension 

The Federal Food, Drug, and Cosmetic 

Act (the act), as amended by the 

Medical Device User Fee and 

Modernization Act of 2002 (Public Law 

107–250), and the Medical Device User 

Fee Amendments of 2007 (Title II of the 

Food and Drug Administration 

Amendments Act of 2007), authorizes 

FDA to collect user fees for certain 

medical device applications. Under this 

authority, companies pay a fee for 

certain new medical device applications 

or supplements submitted to the agency 

for review. Because the submission of 

user fees concurrently with applications 

and supplements is required, the review 

of an application cannot begin until the 

fee is submitted. Form FDA 3601, the 

‘‘Medical Device User Fee Cover Sheet,’’ 

is designed to provide the minimum 

necessary information to determine 

whether a fee is required for review of 

an application, to determine the amount 

of the fee required, and to account for 

and track user fees. The form provides 

a cross-reference between the fees 

submitted for an application with the 

actual submitted application by using a 

unique number tracking system. The 

information collected is used by FDA’s 

Center for Devices and Radiological 

Health (CDRH) and the Center for 

Biologics Evaluation and Research 

(CBER) to initiate the administrative 

screening of new medical device 

applications and supplemental 

applications. 

The total number of annual responses 

is based on the number of cover sheet 

submissions received by FDA in fiscal 

year (FY) 2008. CDRH received 

approximately 5,095 annual responses 

that included the following 

submissions: 16 premarket approval 

applications (PMA) (PMA, PDP, PMR, 

BLA),1 3,625 premarket notifications, 8 

modular premarket applications, 9 

panel track supplements, 201 real-time 

supplements, 173 one hundred eightyday supplements, 633 thirty-day 

notices, ninety-three 513(g) requests, 

and 337 annual fees for periodic 

reporting. 

CBER received approximately 97 

annual responses that included the 

following submissions: 2 premarket 

approval applications (PMA, PDP, PMR, 

BLA), 1 BLA efficacy supplement, 50 

premarket notifications, 3 one hundred 

eighty-day supplements, 2 real-time 

supplements, 20 thirty-day notices, 

3hree 513(g) requests, and 16 annual 

fees for periodic reporting. 

The number of received annual 

responses in FY 2008 included the 

cover sheets for applications that were 

qualified for small businesses and fee 

waivers or reductions. The estimated 

hours per response are based on past 

FDA experience with the various cover 

sheet submissions, and range from 5 to 

30 minutes. The hours per response are 

based on the average of these estimates. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Form FDA No. No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

3601 5,192 1 5,192 .30 1,557.6 

Total Hours 1,557.6 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

mstockstill on DSKH9S0YB1PROD with NOTICES

Federal Register / Vol. 74, No. 198 / Thursday, October 15, 2009 / Notices 52967 

Dated: October 7, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–24825 Filed 10–14–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0488] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Records and 

Reports Concerning Experience With 

Approved New Animal Drugs; Adverse 

Event Reports on Forms FDA 1932, 

1932a, and 2301 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

requirements for recordkeeping and 

reports concerning experience with 

approved new animal drugs. The 

information contained in the reports 

required by the regulation enables FDA 

to monitor the use of new animal drugs 

after approval and to ensure their 

continued safety and efficacy. 

DATES: Submit written or electronic 

comments on the collection of 

information by December 14, 2009. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley Jr, Office of Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3793. 

SUPPLEMENTARY INFORMATION: 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. 

‘‘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 (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Records and Reports Concerning 

Experience With Approved New 

Animal Drugs; Adverse Event Reports 

on Forms FDA 1932, 1932a, and 2301— 

21 CFR Section 514.80 (OMB No. 0910– 

0284)—Extension 

Sections 512(l) of the Federal Food, 

Drug, and Cosmetic Act (the act) (21 

U.S.C. 360b(l)) and § 514.80 (21 CFR 

514.80) of FDA regulations require 

applicants of approved new animal drug 

applications (NADAs) and abbreviated 

new animal drug applications 

(ANADAs) to report adverse drug 

experiences and product/manufacturing 

defects (see § 514.80(b)). 

This continuous monitoring of 

approved NADAs and ANADAs affords 

the primary means by which FDA 

obtains information regarding potential 

problems with the safety and efficacy of 

marketed approved new animal drugs as 

well as potential product/manufacturing 

problems. Postapproval marketing 

surveillance is important because data 

previously submitted to FDA may not be 

adequate, as animal drug effects can 

change over time and less apparent 

effects may take years to manifest. 

Under § 514.80(d), an applicant must 

report adverse drug experiences and 

product/manufacturing defects on Form 

FDA 1932, ‘‘Veterinary Adverse Drug 

Reaction, Lack of Effectiveness, Product 

Defect Report.’’ Periodic drug 

experience reports and special drug 

experience reports must be 

accompanied by a completed Form FDA 

2301, ‘‘Transmittal of Periodic Reports 

and Promotional Material for New 

Animal Drugs’’ (see § 514.80(d)). Form 

FDA 1932a, ‘‘Veterinary Adverse Drug 

Reaction, Lack of Effectiveness or 

Product Defect Report’’ allows for 

voluntary reporting of adverse drug 

experiences or product/manufacturing 

defects. 

The electronic versions of Forms FDA 

1932 and 1932a have been incorporated 

into the agency-wide information 

collection (MedWatchPlus Portal and 

Rational Questionnaire) that was 

announced for public comment in the 

Federal Register of October 23, 2008 (73 

FR 63153). MedWatchPlus Portal and 

Rational Questionnaire is part of a new 

electronic system for collecting, 

submitting, and processing adverse 

event reports and other safety 

information for all FDA-regulated 

products. In the Federal Register of May 

20, 2009 (74 FR 23721), FDA announced 

the submission for OMB review and 

clearance of the electronic data 

collection using MedWatchPlus Portal 

and Rational Questionnaire. 

Burden hours for the electronic 

versions of these forms were included as 

part of the MedWatchPlus Portal and 

Rationale Questionnaire information 

collection approved under OMB control 

number 0910–0645. It is estimated that, 

during the first 3 years that the 

MedWatchPlus Portal is in use, half of 

the reports will be submitted in paper 

format and half will be submitted 

electronically. In order to avoid double 

counting, an estimated 50 percent of 

total annual responses for FDA Form 

1932 (404) and FDA Form 1932a (81.5) 

are counted here as part of OMB control 

number 0910–0284 for the paper 

versions of Forms FDA 1932 and 1932a, 

and an estimated 50 percent of the total 

annual responses (404) and (81.5) for 

Form FDA 1932 and FDA Form 1932a 

respectively, are counted as part of OMB 

control number 0910–0645 for the 

electronic reporting of these adverse 

reports using the MedWatchPlus Portal. 

The paper versions of Forms FDA 

1932 and 1932a, as well as Form FDA 

mstockstill on DSKH9S0YB1PROD with NOTICES