Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Notices 79001 

and acceptability of its services, 

developments in the health status of its 

enrollees, and other matters that CMS 

may require. Data collected via 

Medicare Part C Reporting 

Requirements will be an integral 

resource for oversight, monitoring, 

compliance and auditing activities 

necessary to ensure quality provision of 

the benefits provided by MA plans to 

enrollees. Form Number: CMS–10261 

(OMB# 0938–1054); Frequency: Yearly, 

Quarterly; Affected Public: Business or 

other for-profits; Number of 

Respondents: 588; Total Annual 

Responses: 1158; Total Annual Hours: 

245,528. (For policy questions regarding 

this collection contact Terry Leid at 

410–786–8973. For all other issues call 

410–786–1326.) 

4. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Medicare Part D 

Reporting Requirements and Supporting 

Regulations; Use: 42 CFR part 423, 

§ 423.514, requires each Part D Sponsor 

to have an effective procedure to 

provide statistics indicating: the cost of 

its operations, the patterns of utilization 

of its services, the availability, 

accessibility, and acceptability of its 

services, information demonstrating it 

has a fiscally sound operation and other 

matters as required by CMS. In addition, 

subsection 423.505 of the Medicare 

Prescription Drug, Improvement, and 

Modernization Act (MMA), establishes 

as a contract provision that Part D 

Sponsors must comply with the 

reporting requirements for submitting 

drug claims and related information to 

CMS. Data collected via Medicare Part 

D Reporting Requirements will be an 

integral resource for oversight, 

monitoring, compliance and auditing 

activities necessary to ensure quality 

provision of the Medicare Prescription 

Drug Benefit to beneficiaries. Data will 

be validated, analyzed, and utilized for 

trend reporting by the Division of 

Clinical and Operational Performance 

(DCOP) within the Medicare Drug 

Benefit Group. Form Number: CMS– 

10185 (OMB#: 0938–0992); Frequency: 

Yearly, Quarterly, Semi-Annually; 

Affected Public: Private sector, business 

or other for-profit; Number of 

Respondents: 2993; Total Annual 

Responses: 48,490; Total Annual Hours: 

128,754. (For policy questions regarding 

this collection contact LaToyia Grant at 

410–786–5434. For all other issues call 

410–786–1326.) 

5. Type of Information Collection 

Request: New collection; Title of 

Information Collection: Collection of 

Encounter Data from Medicare 

Advantage Organizations; Use: The 

Centers for Medicare and Medicaid 

Services (CMS) intends to collect 

encounter data, or data on each item or 

service delivered to an enrollee, from 

Medicare Advantage Organizations. 

Medicare Advantage organizations will 

obtain this data from providers. CMS 

would collect the data electronically 

from Medicare Advantage Organizations 

via the Health Insurance Portability and 

Accountability Act (HIPAA) compliant 

standard Health Care Claims 

transactions for professional data and 

institutional data. The information is 

used to submit health care claims or 

equivalent health encounter 

information, carry out health plan 

enrollments and disenrollments, 

determine health plan eligibility, send 

and receive health care payment and 

remittance advices, transmit health plan 

premium payments, determine health 

care claim status, provide referral 

certifications and authorizations, and 

coordinate the benefits for individuals 

who have more than one health plan. 

Form Number: CMS–10340 (OMB#: 

0938–New); Frequency: Weekly; 

Affected Public: Private sector; 

businesses or other for-profits; Number 

of Respondents: 678; Total Annual 

Responses: 384,041,063; Total Annual 

Hours: 768. (For policy questions 

regarding this collection contact Sean 

Creighton at 410–786–9302 or Deondra 

Moseley at 410–786–4577. For all other 

issues call 410–786–1326.) 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS’ Web Site 

at http://www.cms.hhs.gov/ 

PaperworkReductionActof1995, or Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov, or call the 

Reports Clearance Office on (410) 786– 

1326. 

In commenting on the proposed 

information collections please reference 

the document identifier or OMB control 

number. To be assured consideration, 

comments and recommendations must 

be submitted in one of the following 

ways by February 15, 2011: 

1. Electronically. You may submit 

your comments electronically to http:// 

www.regulations.gov. Follow the 

instructions for ‘‘Comment or 

Submission’’ or ‘‘More Search Options’’ 

to find the information collection 

document(s) accepting comments. 

2. By regular mail. You may mail 

written comments to the following 

address: CMS, Office of Strategic 

Operations and Regulatory Affairs, 

Division of Regulations Development, 

Attention: Document Identifier/OMB 

Control Number, Room C4–26–05, 7500 

Security Boulevard, Baltimore, 

Maryland 21244–1850. 

Dated: December 10, 2010. 

Martique Jones, 

Director, Regulations Development DivisionB, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2010–31541 Filed 12–16–10; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0627] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Application for 

Food and Drug Administration 

Approval to Market a New Drug 

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 governing applications for 

FDA approval to market a new drug. 

DATES: Submit either electronic or 

written comments on the collection of 

information by February 15, 2011. 

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: 

Elizabeth Berbakos, Office of 

Information Management, Food and 

Drug Administration, 1350 Piccard Dr., 

P150–400B, Rockville, MD 20850, 301– 

796–3792, 

Elizabeth.Berbakos@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 


emcdonald on DSK2BSOYB1PROD with NOTICES
79002 Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Notices 

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. 

Application for FDA Approval to 

Market a New Drug—(OMB Control 

Number 0910–0001)—Extension 

Under section 505(a) of the Federal 

Food, Drug, and Cosmetic Act (the 

FD&C Act) (21 U.S.C. 355(a)), a new 

drug may not be commercially marketed 

in the United States, imported or 

exported from the United States, unless 

an approval of an application filed with 

FDA under section 505(b) or 505(j) of 

the FD&C Act is effective with respect 

to such a drug. Under the FD&C Act, it 

is the sponsor’s responsibility to 

provide the information needed by FDA 

to make a scientific and technical 

determination whether the product is 

safe and effective for use. 

This information collection approval 

request is for all information 

requirements imposed by the 

regulations under part 314 (21 CFR 314) 

on sponsors who apply for approval of 

a new drug application (NDA) or 

abbreviated new drug application 

(ANDA) in order to market or to 

continue to market a drug. 

Section 314.50(a) requires that the 

applicant submit an application form 

(Form FDA 356h) that includes 

introductory information about the drug 

as well as a checklist of enclosures. 

Section 314.50(b) requires that the 

applicant submit an index with the 

archival copy of the application and that 

it reference certain sections of the 

application. 

Section 314.50(c) requires that the 

applicant submit a summary of the 

application that presents a good general 

synopsis of all the technical sections 

and other information in the 

application. 

Section 314.50(d) requires that the 

NDA contain the following technical 

sections about the new drug: Chemistry, 

manufacturing, and controls; 

nonclinical pharmacology and 

toxicology; human pharmacokinetics 

and bioavailability; microbiology; 

clinical data; statistical; and pediatric 

use sections. 

Section 314.50(e) requires that the 

applicant submit samples of the drug if 

requested by FDA. In addition, the 

archival copy of the application must 

include copies of the label and all 

labeling for the drug. 

Section 314.50(f) requires that the 

applicant submit case report forms and 

tabulations with the archival copy. 

Section 314.50(h) requires that the 

applicant submit patent information, as 

described under § 314.53, with the 

application. (The burden hours for 

§ 314.50(h) are already approved by 

OMB under OMB control number 0910– 

0513 and are not included in the burden 

estimates in table 1 of this document.) 

Section 314.50(i) requires that the 

applicant submit patent certification 

information in section 505(b)(2) 

applications for patents claiming the 

drug, drug product, or method of use. 

Section 314.50(j) requires that 

applicants that request a period of 

marketing exclusivity submit certain 

information with the application. 

Section 314.50(l) requires that the 

applicant submit an archival, review, 

and field copy of the application. 

Section 314.52 requires that a section 

505(b)(2) applicant that relies on a listed 

drug send any notice of certification of 

invalidity or noninfringement of a 

patent to each patent owner and the 

NDA holder . At the time notice is 

provided, a 505(b)(2) applicant is 

required to amend its application to 

include a statement certifying that the 

required notice has been provided. A 

section 505(b)(2) applicant also is 

required to amend its application to 

document receipt of the required notice. 

Section 314.54 sets forth the content 

requirements for applications filed 

under section 505(b)(2) of the FD&C Act. 

(The information collection burden 

estimate for section 505(b)(2) 

applications is included in table 1 of 

this document under the estimates for 

§ 314.50(a), (b), (c), (d), (e), (f), and (k)). 

Section 314.60 sets forth reporting 

requirements for sponsors who amend 

an unapproved application. 

Section 314.65 states that the sponsor 

must notify FDA when withdrawing an 

unapproved application. 

Sections 314.70 and 314.71 require 

that applicants submit supplements to 

FDA for certain changes to an approved 

application. 

Section 314.72 requires that sponsors 

report to FDA any transfer of ownership 

of an application. 

Section 314.80(c)(1) and (c)(2) sets 

forth requirements for expedited 

adverse drug experience postmarketing 

reports and followup reports, as well as 

for periodic adverse drug experience 

postmarketing reports (Form FDA 

3500A). (The burden hours for 

§ 314.80(c)(1) and (c)(2) are already 

approved by OMB under OMB control 

numbers 0910–0230 and 0910–0291 and 

are not included in the burden estimates 

in table 1 of this document.) 

Section 314.80(i) establishes 

recordkeeping requirements for reports 

of postmarketing adverse drug 

experiences. (The burden hours for 

§ 314.80(i) are already approved by 

OMB under OMB control numbers 

0910–0230 and 0910–0291 and are not 

included in the burden estimates in 

table 1 of this document.) 

Section 314.81(b)(1) requires that 

applicants submit field alert reports to 

FDA (Form FDA 3331). 

Section 314.81(b)(2) requires that 

applicants submit annual reports to 

FDA (Form FDA 2252). 

Section 314.81(b)(3)(i) requires that 

applicants submit drug advertisements 

and promotional labeling to FDA (Form 

FDA 2253). 

Section 314.81(b)(3)(iii) sets forth 

reporting requirements for sponsors 

who withdraw an approved drug 

product from sale. (The burden hours 

for § 314.81(b)(3)(iii) are already 

approved by OMB under OMB control 

number 0910–0045 and are not included 

in the burden estimates in table 1 of this 

document.) 

Section 314.90 sets forth requirements 

for sponsors who request waivers from 

FDA for compliance with §§ 314.50 

through 314.81. (The information 

collection burden estimate for NDA 

waiver requests is included in table 1 of 

this document under estimates for 

§§ 314.50, 314.60, 314.70, and 314.71.) 


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Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Notices 79003 

Section 314.93 sets forth requirements 

for submitting a suitability petition in 

accordance with 21 CFR 10.20 and 

10.30. (The burden hours for § 314.93 

are already approved by OMB under 

OMB control number 0910–0183 and 

are not included in the burden estimates 

in table 1 of this document.) 

Section 314.94(a) and (d) requires that 

an ANDA contain the following 

information: Application form; table of 

contents; basis for ANDA submission; 

conditions of use; active ingredients; 

route of administration, dosage form, 

and strength; bioequivalence; labeling; 

chemistry, manufacturing, and controls; 

samples; patent certification. 

Section 314.95 requires that ANDA 

applicants send any notice of 

certification of invalidity or 

noninfringement of a patent to each 

patent owner and the NDA holder. 

Section 314.96 sets forth requirements 

for amendments to an unapproved 

ANDA. 

Section 314.97 sets forth requirements 

for submitting supplements to an 

approved ANDA for changes that 

require FDA approval. 

Section 314.98(a) sets forth 

postmarketing adverse drug experience 

reporting and recordkeeping 

requirements for ANDAs. (The burden 

hours for § 314.98(a) are already 

approved by OMB under OMB control 

numbers 0910–0230 and 0910–0291 and 

are not included in the burden estimates 

in table 1 of this document.) 

Section 314.98(c) requires other 

postmarketing reports for ANDAs: Field 

alert reports (Form FDA 3331), annual 

reports (Form FDA 2252), and 

advertisements and promotional 

labeling (Form FDA 2253). (The 

information collection burden estimate 

for field alert reports is included in table 

1 of this document under § 314.81(b)(1); 

the estimate for annual reports is 

included under § 314.81(b)(2); the 

estimate for advertisements and 

promotional labeling is included under 

§ 314.81(b)(3)(i).) 

Section 314.99(a) requires that 

sponsors comply with certain reporting 

requirements for withdrawing an 

unapproved ANDA and for a change in 

ownership of an ANDA. 

Section 314.99(b) sets forth 

requirements for sponsors who request 

waivers from FDA for compliance with 

§§ 314.92 through 314.99. (The 

information collection burden estimate 

for ANDA waiver requests is included 

in table 1 of this document under 

estimates for § 314.94(a) and (d) and 

§§ 314.96 and 314.97.) 

Section 314.101(a) states that if FDA 

refuses to file an application, the 

applicant may request an informal 

conference with FDA and request that 

the application be filed over protest. 

Section 314.107(c) requires that the 

first applicant who submits a 

substantially complete ANDA 

containing a certification that a relevant 

patent is invalid, unenforceable, or will 

not be infringed submit notice to FDA 

of the date of first commercial marketing 

of its drug product. 

Section 314.107(e) requires that an 

applicant submit a copy of the entry of 

the order or judgment to FDA within 10 

working days of a final judgment. 

Section 314.107(f) requires that 

ANDA or section 505(b)(2) applicants 

notify FDA immediately of the filing of 

any legal action filed within 45 days of 

receipt of the notice of certification. A 

patent owner may also notify FDA of the 

filing of any legal action for patent 

infringement. If the patent owner or 

approved application holder who is an 

exclusive patent licensee waives its 

opportunity to file a legal action for 

patent infringement within the 45-day 

period, the patent owner or approved 

application holder must submit to FDA 

a waiver in the specified format. 

Section 314.110(b)(3) states that, after 

receipt of an FDA complete response 

letter, an applicant may request an 

opportunity for a hearing on the 

question of whether there are grounds 

for denying approval of the application. 

(The burden hours for § 314.110(b)(3) 

are included under parts 10 through 16 

(21 CFR parts 10 and 16) hearing 

regulations, in accordance with 

§ 314.201, and are not included in the 

burden estimates in table 1 of this 

document.) 

Section 314.110(c) states that, after 

receipt of a complete response letter, an 

applicant may notify FDA that it agrees 

to an extension of the review period so 

that it can determine whether to 

respond further. 

Section 314.122(a) requires that an 

ANDA or a suitability petition that 

relies on a listed drug that has been 

voluntarily withdrawn from sale must 

be accompanied by a petition seeking a 

determination whether the drug was 

withdrawn for safety or effectiveness 

reasons. (The burden hours for 

§ 314.122(a) are already approved by 

OMB under OMB control number 0910– 

0183 and are not included in the burden 

estimates in table 1 of this document.) 

Section 314.122(d) sets forth 

requirements for relisting petitions for 

unlisted discontinued products. (The 

burden hours for § 314.122(d) are 

already approved by OMB under OMB 

control number 0910–0183 and are not 

included in the burden estimates in 

table 1 of this document.) 

Section 314.126(c) sets forth 

requirements for a petition to waive 

criteria for adequate and well-controlled 

studies. (The burden hours for 

§ 314.126(c) are already approved by 

OMB under OMB control number 0910– 

0183 and are not included in the burden 

estimates in table 1 of this document.) 

Section 314.151(a) and (b) sets forth 

requirements for the withdrawal of 

approval of an ANDA and the 

applicant’s opportunity for a hearing 

and submission of comments. (The 

burden hours for § 314.151(a) and (b) are 

included under parts 10 through 16 

hearing regulations, in accordance with 

§ 314.201, and are not included in the 

burden estimates in table 1 of this 

document.) 

Section 314.151(c) sets forth the 

requirements for withdrawal of approval 

of an ANDA and the applicant’s 

opportunity to submit written objections 

and participate in a limited oral hearing. 

(The burden hours for § 314.151(c) are 

included under parts 10 through 16 

hearing regulations, in accordance with 

§ 314.201, and are not included in the 

burden estimates in table 1 of this 

document.) 

Section 314.153(b) sets forth the 

requirements for suspension of an 

ANDA when the listed drug is 

voluntarily withdrawn for safety and 

effectiveness reasons, and the 

applicant’s opportunity to present 

comments and participate in a limited 

oral hearing. (The burden hours for 

§ 314.152(b) are included under parts 10 

through 16 hearing regulations, in 

accordance with § 314.201, and are not 

included in the burden estimates in 

table 1 of this document.) 

Section 314.161(b) and (e) sets forth 

the requirements for submitting a 

petition to determine whether a listed 

drug was voluntarily withdrawn from 

sale for safety or effectiveness reasons. 

(The burden hours for § 314.161(b) and 

(e) are already approved by OMB under 

OMB control number 0910–0183 and 

are not included in the burden estimates 

in table 1 of this document.) 

Section 314.200(c), (d), and (e) 

requires that applicants or others subject 

to a notice of opportunity for a hearing 

who wish to participate in a hearing file 

a written notice of participation and 

request for a hearing as well as the 

studies and data on which they relied. 

Other interested persons may also 

submit comments on the notice. The 

section also sets forth the content and 

format requirements for the applicants’ 

submission in response to notice of 

opportunity for hearing. (The burden 

hours for § 314.200(c), (d), and (e) are 

included under parts 10 through 16 

hearing regulations, in accordance with 


emcdonald on DSK2BSOYB1PROD with NOTICES
79004 Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Notices 

§ 314.201, and are not included in the 

burden estimates in table 1 of this 

document.) 

Section 314.200(f) states that 

participants in a hearing may make a 

motion to the presiding officer for the 

inclusion of certain issues in the 

hearing. (The burden hours for 

§ 314.200(f) are included under parts 10 

through 16 hearing regulations, in 

accordance with § 314.201, and are not 

included in the burden estimates in 

table 1 of this document.) 

Section 314.200(g) states that a person 

who responds to a proposed order from 

FDA denying a request for a hearing 

provide sufficient data, information, and 

analysis to demonstrate that there is a 

genuine and substantial issue of fact 

which justifies a hearing. (The burden 

hours for § 314.200(g) are included 

under parts 10 through 16 hearing 

regulations, in accordance with 

§ 314.201, and are not included in the 

burden estimates in table 1 of this 

document.) 

Section 314.420 states that an 

applicant may submit to FDA a drug 

master file in support of an application, 

in accordance with certain content and 

format requirements. 

Section 314.430 states that data and 

information in an application are 

disclosable under certain conditions, 

unless the applicant shows that 

extraordinary circumstances exist. (The 

burden hours for § 314.430 are included 

under parts 10 through 16 hearing 

regulations, in accordance with 

§ 314.201, and are not included in the 

burden estimates in table 1 of this 

document.) 

Section 314.530(c) and (e) states that 

if FDA withdraws approval of a drug 

approved under the accelerated 

approval procedures, the applicant has 

the opportunity to request a hearing and 

submit data and information. (The 

burden hours for § 314.530(c) and (e) are 

included under parts 10 through 16 

hearing regulations, in accordance with 

§ 314.201, and are not included in the 

burden estimates in table 1 of this 

document.) 

Section 314.530(f) requires that an 

applicant first submit a petition for stay 

of action before requesting an order 

from a court for a stay of action pending 

review. (The burden hours for 

§ 314.530(f) are already approved by 

OMB under OMB control number 0910– 

0194 and are not included in the burden 

estimates in table 1 of this document.) 

Section 314.610(b)(1) requires that 

applicants include a plan or approach to 

postmarketing study commitments in 

applications for approval of new drugs 

when human efficacy studies are not 

ethical or feasible, and that applicants 

provide status reports of postmarketing 

study commitments. (The information 

collection burden estimate for 

§ 314.610(b)(1) is included in table 1 of 

this document under the estimates for 

§§ 314.50 (a), (b), (c), (d), (e), (f), and (k) 

and 314.81(b)(2)). 

Section 314.610(b)(3) requires that in 

applications for approval of new drugs 

when human efficacy studies are not 

ethical or feasible applicants propose 

labeling to provide to patient recipients. 

(The information collection burden 

estimate for § 314.610(b)(3) is included 

in table 1 of this document under the 

estimates for § 314.50(e)). 

Section 314.630 requires that 

applicants provide postmarketing safety 

reporting for applications for approval 

of new drugs when human efficacy 

studies are not ethical or feasible. (The 

burden hours for § 314.630 are already 

approved by OMB under OMB control 

numbers 0910–0230 and 0910–0291 and 

are not included in the burden estimates 

in table 1 of this document.) 

Section 314.640 requires that 

applicants provide promotional 

materials for applications for approval 

of new drugs when human efficacy 

studies are not ethical or feasible. (The 

information collection burden estimate 

for § 314.640 is included in table 1 of 

this document under the estimates for 

§ 314.81(b)(3)(i)). 

Respondents to this collection of 

information are all persons who submit 

an application or abbreviated 

application or an amendment or 

supplement to FDA under part 314 to 

obtain approval of a new drug, and any 

person who owns an approved 

application or abbreviated application. 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR Section; [Form Number] No. of 

respondents 

Annual 

frequency per 

response 

Total annual 

responses 

Hours per 

response Total hours 

314.50 (a), (b), (c), (d), (e), (f), and (k) ............................. 92 1 .36 126 1,917 241,542 

314.50(i) and 314.94(a)(12) ............................................... 96 9 .61 923 2 1,846 

314.50(j) ............................................................................. 71 4 .02 286 2 572 

314.52 and 314.95 ............................................................. 71 3 .66 260 16 4,160 

314.60 ................................................................................ 349 21 .67 7,564 80 605,120 

314.65 ................................................................................ 10 1 .20 12 2 24 

314.70 and 314.71 ............................................................. 620 4 .91 3,050 150 457,500 

314.72 ................................................................................ 104 2 .98 310 2 620 

314.81(b)(1) [3331] ............................................................ 147 2 .57 378 8 3,024 

314.81(b)(2) [2252] ............................................................ 656 13 .84 9,084 40 363,360 

314.81(b)(3)(i) [2253] ......................................................... 490 61 .48 30,130 2 60,260 

314.94(a)(1)–(11) and (d) .................................................. 110 7 .83 862 480 413,760 

314.96 ................................................................................ 292 35 .82 10,461 80 836,880 

314.97 ................................................................................ 197 26 .23 5,169 80 413,520 

314.99(a) ............................................................................ 53 2 .30 122 2 244 

314.101(a) .......................................................................... 1 1 1 .50 .50 

314.107(c)— ...................................................................... 56 4 .1 230 .50 115 

314.107(e)— ...................................................................... 25 3 .92 98 .50 49 

314.107(f)— ....................................................................... 56 4 .1 230 .50 115 

314.110(c) .......................................................................... 11 1 .36 15 .50 7.5 

314.420 .............................................................................. 524 1 .98 1,038 61 63,318 

Total ............................................................................ ........................ .......................... ........................ ........................ 3,466,037 

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


emcdonald on DSK2BSOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Notices 79005 

Dated: December 13, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–31693 Filed 12–16–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0235] 

Ehigiator O. Akhigbe: Debarment 

Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is issuing an 

order under the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) debarring 

Ehigiator O. Akhigbe, MD for 25 years 

from providing services in any capacity 

to a person that has an approved or 

pending drug product application. We 

base this order on a finding that Dr. 

Akhigbe was convicted of 17 felonies for 

conduct involving fraud, false statement 

and falsification or destruction of 

records. Dr. Akhigbe was given notice of 

the proposed debarment and an 

opportunity to request a hearing within 

the timeframe prescribed by regulation. 

Dr. Akhigbe failed to respond. Dr. 

Akhigbe’s failure to respond constitutes 

a waiver of his right to a hearing 

concerning this action. 

DATES: This Order is effective December 

17, 2010. 

ADDRESSES: Submit applications for 

termination of debarment to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Kenny Shade, Office of Regulatory 

Affairs, Food and Drug Administration, 

5600 Fishers Lane, Rockville, MD 

20857, 240–632–6844. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 306(b)(2)(B)(ii)(I) of the FD&C 

Act (21 U.S.C. 335a(b)(2)(B)(ii)(I)) 

permits FDA to debar an individual if it 

finds that the individual has been 

convicted of a felony which involves 

bribery, payment of illegal gratuities, 

fraud, perjury, false statement, 

racketeering, blackmail, extortion, 

falsification or destruction of records, or 

interference with, obstruction of an 

investigation into, or prosecution of, any 

criminal offense, and it finds, on the 

basis of the conviction and other 

information, that such individual has 

demonstrated a pattern of conduct 

sufficient to find that there is reason to 

believe that individual may violate 

requirements under the Act relating to 

drug products. 

On March 19, 2010, the United States 

District Court for the District of 

Columbia entered judgment against Dr. 

Akhigbe for one count of health care 

fraud in violation of 18 U.S.C. 1347, and 

16 counts of false statements in health 

care matters in violation of 18 U.S.C. 

1035. 

FDA’s finding that debarment is 

appropriate is based on the felony 

convictions referenced herein. The 

factual basis for those convictions is as 

follows: Dr. Akhigbe was a medical 

doctor with licenses to practice in the 

District of Columbia, Maryland, 

Pennsylvania, and Virginia. The District 

of Columbia Medicaid Program 

contracted with Amerigroup Corp. 

(Amerigroup) to act as its fiscal agent for 

the processing and payment of claims 

submitted by Medicaid providers. On or 

about December 6, 2001, Dr. Akhigbe 

entered into a Participating Physician 

Agreement with Amerigroup whereby 

he agreed to provide healthcare services 

to District of Columbia Medicaid 

beneficiaries. 

Dr. Akhigbe prepared and submitted 

his own billing to Amerigroup for 

medical services he purportedly 

provided to his patients. For each billed 

visit, Dr. Akhigbe or others acting at his 

direction, generated insurance claim 

forms which included his certification 

that all of the information on the claim 

forms was accurate. From on or about 

December 6, 2001, until the termination 

of his contract with Amerigroup on June 

24, 2004, Dr. Akhigbe submitted 

approximately 3,957 claims to 

Amerigroup for services he purportedly 

provided to Medicaid patients and 

sought approximately $807,347.00 from 

Amerigroup. 

Beginning in approximately December 

2002, and continuing to approximately 

May 2005, in the District of Columbia 

and elsewhere, Dr. Akhigbe knowingly, 

willfully, and with intent to defraud, 

executed a scheme and artifice to 

defraud Amerigroup as to material 

matters in connection with the delivery 

of any payment for health care benefits, 

items, and services, and to obtain 

money from Amerigroup by means of 

material false and fraudulent pretenses 

and representations and the 

concealment of material facts in 

connection with the delivery of and 

payment for health care benefits, items, 

and services. As part of his scheme, Dr. 

Akhigbe repeatedly prepared and 

submitted false claims in which he 

purported to have performed surgical or 

invasive medical procedures on District 

of Columbia Medicaid patients that 

were never performed, he billed for 

office visits that never occurred, and he 

continued to bill for a period of time 

after a minor or major procedure during 

which no additional bills could be 

submitted. In order to conceal from 

Amerigroup that he was billing for 

procedures that he had not performed, 

Dr. Akhigbe created false progress notes 

indicating the dates, times and medical 

procedures that he claimed to have 

performed and inserted the false 

progress notes into his patients’ medical 

files to corroborate a number of false 

claims. 

As a result of his convictions, on 

September 13, 2010, FDA sent Dr. 

Akhigbe a notice by certified mail 

proposing to debar him for 25 years 

from providing services in any capacity 

to a person that has an approved or 

pending drug product application. The 

proposal was based on a finding, under 

section 306(b)(2)(B)(ii)(I) of the FD&C 

Act (21 U.S.C. 335a(b)(2)(B)(ii)(I)), that 

Dr. Akhigbe was convicted of felonies 

for conduct involving fraud, false 

statement and falsification or 

destruction of records and that Dr. 

Akhigbe has demonstrated a pattern of 

conduct sufficient to find that there is 

reason to believe that individual may 

violate requirements under the FD&C 

Act relating to drug products. The 

proposal also offered Dr. Akhigbe an 

opportunity to request a hearing, 

providing him 30 days from the date of 

receipt of the letter in which to file the 

request, and advised him that failure to 

request a hearing constituted a waiver of 

the opportunity for a hearing and of any 

contentions concerning this action. Dr. 

Akhigbe failed to respond within the 

timeframe prescribed by regulation and 

has, therefore, waived his opportunity 

for a hearing and waived any 

contentions concerning his debarment 

(21 CFR part 12). 

II. Findings and Order 

Therefore, the Director, Office of 

Enforcement, Office of Regulatory 

Affairs, under Section 306(b)(2)(B)(ii)(I) 

of the FD&C Act (21 U.S.C. 

335a(b)(2)(B)(ii)(I)) under authority 

delegated to him (Staff Manual Guide 

1410.35), finds that Ehigiator O. 

Akhigbe has been convicted of felonies 

for conduct involving fraud, false 

statement and falsification or 

destruction of records. 

As a result of the foregoing finding, 

Dr. Akhigbe is debarred for 25 years 

from providing services in any capacity 

to a person with an approved or 


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