62808 Federal Register / Vol. 76, No. 196 / Tuesday, October 11, 2011 / Notices 

falsified the calcium response data in 

Figure 5A (right panel) of the grant 

application referenced above by adding 

ATP as a reagent to the mouse airway 

epithelial cells to sharpen the results 

purported to be caused by PGN without 

disclosing that ATP had been added and 

without disclosing that ATP was not 

added to the control sample. 

The questioned research was not 

submitted for publication. 

Dr. Sanyal has entered into a 

Voluntary Settlement Agreement with 

ORI and Duke, in which he voluntarily 

agreed to the administrative actions set 

forth below. The administrative actions 

are required for two (2) years beginning 

on the date of Dr. Sanyal’s employment 

in a research position in which he 

receives or applies for PHS support on 

or after the effective date of the 

Agreement (September 16, 2011); 

however, if he has not obtained 

employment in a research position in 

which he receives or applies for PHS 

support within three (3) years of the 

effective date of the Agreement, the 

administrative actions set forth below 

will no longer apply. Dr. Sanyal has 

voluntarily agreed: 

(1) To have his research supervised as 

described below and to notify his 

employer(s)/institutions(s) of the terms 

of this supervision; Respondent agrees 

to ensure that prior to the submission of 

an application for PHS support for a 

research project on which Respondent’s 

participation is proposed and prior to 

Respondent’s participation in any 

capacity on PHS supported research, the 

institution employing him will submit a 

plan for supervision of Respondent’s 

duties to ORI for approval; the plan for 

supervision must be designed to ensure 

the scientific integrity of Respondent’s 

research contribution; Respondent 

agrees that he will not participate in any 

PHS supported research from the 

effective date of this Agreement until a 

plan for supervision is submitted to and 

approved by ORI; Respondent agrees to 

be responsible for maintaining 

compliance with the agreed upon plan 

for supervision; 

(2) that any institution employing him 

must submit, in conjunction with each 

application for PHS funds, or report, 

manuscript, or contract involving PHS 

supported research in which 

Respondent is involved, a certification 

to ORI that the data provided by 

Respondent are based on actual 

experiments or are otherwise 

legitimately derived and that the data, 

procedures, and methodology are 

accurately reported in the application, 

report, manuscript, or abstract; and 

(3) to exclude himself from serving in 

any advisory capacity to PHS, including 

but not limited to service on any PHS 

advisory committee, board, and/or peer 

review committee, or as a consultant. 

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. 2011–26127 Filed 10–7–11; 8:45 am] 

BILLING CODE 4150–31–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare and Medicaid 

Services 

[CMS–3180–N2] 

Food and Drug Administration 

[Docket No. FDA–2010–N–0308] 

Pilot Program for Parallel Review of 

Medical Products 

AGENCY: Food and Drug Administration, 

Centers for Medicare and Medicaid 

Services, HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) and the Centers 

for Medicare and Medicaid Services 

(CMS) (the Agencies) are soliciting 

nominations from sponsors of 

innovative device technologies to 

participate in a pilot program for 

concurrent review of certain FDA 

premarket review submissions and CMS 

national coverage determinations. The 

Agencies announced the intention to 

initiate a pilot program in the Federal 

Register of September 17, 2010. The 

Agencies are now providing notice of 

the procedures for voluntary 

participation in the pilot program, as 

well as the guiding principles the 

Agencies intend to follow. 

DATES: Effective Date: November 10, 

2011. 

FOR FURTHER INFORMATION CONTACT:

For device sponsors interested in 

requesting voluntary parallel review: 

Markham C. Luke, Center for Devices 

and Radiological Health, Food and 

Drug Administration, 301–796–5550, 

e-mail: markham.luke@fda.hhs.gov. 

For General questions about parallel 

review: 

Peter Beckerman, Office of Policy, Food 

and Drug Administration, 301–796– 

4830, e-mail: 

peter.beckerman@fda.hhs.gov or 

Tamara Syrek Jensen, Centers for 

Medicare and Medicaid Services, 

410–786–3529, e-mail: 

Tamara.Syrekjensen@cms.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

A. Parallel Review Proposal 

As discussed in the September 17, 

2010, Federal Register notice (75 FR 

57045), parallel review is intended to 

reduce the time between FDA marketing 

approval and CMS national coverage 

determinations, thereby improving the 

quality of patient health care by 

facilitating earlier access to innovative 

medical products for Medicare 

beneficiaries. In the notice of September 

17, 2010, we solicited comments on 

parallel review of submissions to FDA 

and CMS for regulated medical 

products. We also stated our intention 

to initiate a pilot program for parallel 

review of devices. The Agencies 

received 36 comments before the 

comment period closed on December 

16, 2010. The public comments can be 

found at: http://www.regulations.gov, 

identified by docket number FDA– 

2010–N–0308. Major themes of the 

comments included, among others: 

Parallel review should be sponsor/ 

requester initiated, voluntary, and 

include an option to opt out of a 

national coverage determination (NCD); 

agencies should clarify the 

confidentiality standards for data 

sharing between the Agencies; and 

agencies should establish clear and 

concise guidelines on the procedures 

and a timeline for parallel review. These 

comments have informed the parallel 

review pilot program for medical 

devices we are announcing in this 

notice. We also intend to seek input and 

feedback from candidate sponsor/ 

requesters who participate in the pilot. 

Current information describing the 

FDA–CMS Parallel Review Pilot 

Program for Medical Devices can be 

found at the following Web site: 

http://www.parallel-review.fda.gov. 

B. Expected Benefits of Parallel Review 

The expected benefits of an FDA– 

CMS parallel review program were 

discussed in the September 17, 2010, 

notice. The anticipated benefits include 

facilitating development of innovative 

new products and increased efficiency 

in the Agencies’ review processes. 

It has come to our attention that 

innovators have generally focused solely 

on obtaining FDA approval, only to later 

realize that Medicare payment may not 

automatically be forthcoming. 

As stated in the notice of September 

17, 2010, parallel review will serve the 

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Federal Register / Vol. 76, No. 196 / Tuesday, October 11, 2011 / Notices 62809 

public interest by providing the 

possibility of reducing the time between 

FDA marketing approval or clearance 

decisions and Medicare NCDs. The 

efficiencies gained by parallel review 

are expected to benefit all interested 

parties. Patients are expected to gain 

quicker access to innovative medical 

technologies if they are covered. The 

sponsor/requester gains timely insight 

to the information needs of CMS with 

respect to pursuing a positive NCD as 

well as a potentially shortened time to 

payment due to a streamlined multireview process. The Agencies gain 

enhanced channels of communication. 

Specifically with regard to CMS, its 

early involvement will streamline the 

decision making process. It will also 

focus attention on health outcomes of 

importance to Medicare, and provide 

early awareness of any remaining 

evidence gaps. If there are evidence 

gaps, CMS may address them by 

implementing coverage with evidence 

development (CED) or other policy 

vehicles. For example, if FDA approval 

or clearance is conditioned on a postapproval study, CMS could decide to 

cover the device within the parameters 

of the post-approval study under CED. 

II. Parallel Review Pilot Program for 

Medical Devices 

The Agencies have developed a pilot 

program that reflects our review of the 

comments received on the September 

17, 2010, notice and our interest in 

creating a streamlined process with 

minimal additional burden to interested 

sponsor/requesters. This document 

outlines the: (1) Guiding principles 

underlying the pilot program; (2) 

appropriate candidates for the pilot 

program; (3) procedures FDA and CMS 

intend to follow in conducting parallel 

product reviews; and (4) general roles 

and responsibilities of the sponsor/ 

requester, FDA, and CMS. 

A. Guiding Principles 

In response to comments received, the 

Agencies have identified basic 

principles underlying the parallel 

review pilot program described in this 

document. The following principles are 

intended to create a common 

understanding among the sponsor/ 

requester, FDA, and CMS about the 

goals and parameters of the parallel 

review pilot program: 

1. Participation in parallel review will 

not affect the review standard for device 

approval by FDA or for a coverage 

determination by CMS. 

2. The Agencies will adhere to all 

statutory and regulatory requirements as 

stipulated in the memorandum of 

understanding between FDA and CMS, 

available at http://www.fda.gov/ 

aboutfda/partnershipscollaborations/ 

memorandaofunderstandingmous/ 

domesticmous/ucm217585.htm. 

3. A sponsor/requester may withdraw 

from, and FDA and CMS may terminate, 

parallel review up until the time of 

CMS’s public posting of an NCD 

tracking sheet. 

4. The Agencies will not publicly 

disclose participation of a sponsor/ 

requester in parallel review prior to 

CMS’s posting of an NCD tracking sheet, 

unless the sponsor/requester consents or 

has already made this information 

public or disclosure is required by law. 

If a sponsor/requester does not wish the 

information that would be revealed by 

the posting of the NCD tracking sheet to 

become public, it must withdraw from 

parallel review prior to this point. 

5. Due to Agency resource issues the 

pilot program expects to accept no more 

than three to five candidates per year. 

B. Appropriate Candidates 

During its pilot phase, the Agencies 

believe parallel review should focus on 

truly innovative technologies that are 

most likely to benefit from the 

efficiencies of parallel review. 

Accordingly, appropriate candidates for 

the parallel review pilot are medical 

devices which each use the following: 

1. New technologies for which the 

sponsor/requester has had sufficient 

pre-investigational device exemption 

(IDE) interaction with FDA or approved 

IDE application. 

2. New technologies for which an 

original or supplemental application for 

premarket approval (PMA) or petition 

for de novo review would be required. 

3. New technologies that fall within 

the scope of a Part A or Part B Medicare 

benefit category and are not subject to 

an NCD. 

The agencies encourage any interested 

sponsors who believe their devices are 

appropriate candidates and would like 

to explore the use of the pilot program 

to contact FDA by e-mail at: parallelreview@fda.gov, before initiating the 

procedures referenced under section II.C 

of this document entitled ‘‘C. 

Procedures.’’ 

C. Procedures 

For sponsor/requesters of devices that 

have already had contact with FDA 

through the pre-IDE or IDE process, 

much of the information necessary to 

assess the suitability of a candidate 

technology should already be in FDA’s 

possession. The Agencies have 

developed the following procedures to 

ensure adequate information to assess a 

candidate’s suitability for parallel 

review without creating a burdensome 

new application process: 

1. Nomination. The sponsor/requester 

of an innovative therapeutic or 

diagnostic device may nominate its 

device for participation in parallel 

review by following the instructions 

posted on the http://www.parallelreview.fda.gov web page. FDA intends 

to acknowledge receipt of nominations 

by e-mail. The following information 

will assist FDA in processing and 

responding to nominations: 

• Name of the sponsor/requester and 

relevant contact information; 

• Pre-IDE/IDE/PMA/De Novo 

reference number; 

• Name of the product; 

• Succinct description of the 

technology and disease or condition the 

device is intended to diagnose or treat; 

• Stage of development of the 

technology (that is, in preclinical 

testing, in clinical trials, currently 

undergoing premarket review by FDA); 

• Brief statement explaining why the 

device is an appropriate candidate for 

the pilot program as described under the 

section II.B of this document entitled: 

‘‘B. Appropriate Candidates.’’ 

2. FDA/CMS Consideration. The 

Agencies intend to meet to consider a 

nomination within 30 days of receiving 

a complete nomination containing the 

information described previously. The 

Agencies may contact the sponsor/ 

requester to request supplemental 

information. 

3. Sponsor/requester Notification. 

Upon completion of the consideration 

meeting, the Agencies will notify the 

sponsor/requester whether the product 

is an appropriate candidate for the 

parallel review pilot program. 

4. Acceptance Meeting. If deemed an 

appropriate candidate, the Agencies will 

meet with the product sponsor/ 

requester, either in person or by phone. 

5. FDA Review. Parallel review 

candidates will be reviewed according 

the normal FDA review process. 

Participation in parallel review will not 

affect user fees, review timeframes or 

procedures, or the FDA standard of 

approval, which is reasonable assurance 

of safety and effectiveness. 

6. CMS NCD Review and Timing. CMS 

will begin its informal review process 

sometime after submission of the PMA 

or de novo petition. For PMAs, this will 

typically begin after the PMA-specific 

Panel meeting of the FDA Medical 

Devices Advisory Committee. 

D. Roles and Responsibilities 

The Agencies have outlined the 

general roles and responsibilities of 

each participant in the parallel review 

process to ensure clarity and shared 

mstockstill on DSK4VPTVN1PROD with NOTICES

62810 Federal Register / Vol. 76, No. 196 / Tuesday, October 11, 2011 / Notices 

understandings. These roles and 

responsibilities are as follows: 

1. Sponsor/requester. The sponsor/ 

requester initiates consideration for 

parallel review by submitting a 

complete nomination as outlined 

previously under ‘‘1. Nomination,’’ of 

section II.C of this document entitled 

‘‘Procedures.’’. Once a nomination has 

been submitted, the sponsor/requester 

should comply with all requirements 

necessary for FDA review of a PMA or 

de novo petition and CMS issuance of 

an NCD including the submission of a 

formal request for an NCD. The 

Agencies request that a sponsor/ 

requester who wishes to withdraw from 

the parallel review process notify the 

FDA and CMS in writing before CMS’ 

formal opening of an NCD by the 

posting of the NCD tracking sheet. 

2. The FDA. FDA will provide a 

secure and confidential nomination and 

review process as outlined previously in 

section II.C of this document. FDA will 

initiate review of nominations for 

parallel review by retrieving 

applications from the secure mailbox, 

and coordinating with CMS, on the 

planning and implementation of the 

parallel review process. FDA will 

review PMAs and de novo petitions for 

products that have been selected by the 

Agencies for parallel review according 

to the usual timeframes, procedures, 

and review standards for PMA approval 

and de novo classification. 

3. The CMS. In addition to the 

coverage review, CMS’s parallel review 

roles include participating in the 

nomination process as well as 

coordinating with FDA regarding the 

planning and implementation of the 

parallel review process. During the 

parallel review, CMS is responsible for 

maintaining open communication 

channels with FDA and the sponsor/ 

requester and for fulfilling its statutory 

obligations concerning the NCD process. 

E. Duration of the Pilot 

The Agencies intend to accept 

requests for participation in the pilot 

program for parallel review for 2 years. 

The Agencies may terminate the pilot 

program before the close of the 2-year 

period, or may extend the pilot program 

beyond 2 years. The decisions will be 

announced in the Federal Register. 

F. Evaluation 

The Agencies intend to use their 

experience with the pilot program to 

develop a parallel review program not 

only for devices but also for drugs and 

biological products. The Agencies 

anticipate their experience with the 

parallel review program for devices and 

feedback from participants in the 

program will inform guidance for a 

broader program applicable to all 

medical products. The Agencies may 

also determine that they should extend 

or modify the parallel review pilot 

program to continue their evaluation. 

(Catalog of Federal Domestic Assistance 

Program No. 93.778, Medical Assistance 

Program) (Catalog of Federal Domestic 

Assistance Program No. 93.773, Medicare— 

Hospital Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: September 21, 2011. 

Donald M. Berwick, 

Administrator, Centers for Medicare & 

Medicaid Services. 

Dated: September 21, 2011. 

Margaret A. Hamburg, 

Commissioner of Food and Drugs. 

[FR Doc. 2011–25907 Filed 10–6–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0263] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Experiment To 

Evaluate Risk Perceptions of Produce 

Growers, Food Retailers, and 

Consumers After a Food Recall 

Resulting From a Foodborne Illness 

Outbreak 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995 

(the PRA). 

DATES: Fax written comments on the 

collection of information by November 

10, 2011. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–New and 

title ‘‘Experiment to Evaluate Risk 

Perceptions of Produce Growers, Food 

Retailers, and Consumers After a Food 

Recall Resulting From a Foodborne 

Illness Outbreak.’’ Also include the FDA 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley, Jr., Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

3793. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Experiment To Evaluate Risk 

Perceptions of Produce Growers, Food 

Retailers, and Consumers After a Food 

Recall Resulting From a Foodborne 

Illness Outbreak—(OMB Control 

Number 0910—NEW) 

I. Background 

This proposed collection of 

information entitled ‘‘Experiment to 

Evaluate Risk Perceptions of Produce 

Growers, Food Retailers, and Consumers 

After a Food Recall Resulting From a 

Foodborne Illness Outbreak’’ will be 

conducted under a cooperative 

agreement between the Joint Institute for 

Food Safety and Applied Nutrition 

(JIFSAN) and the Center for Risk 

Communication Research (CRCR) at the 

University of Maryland. JIFSAN was 

established in 1996 and is a public and 

private partnership between FDA and 

the University of Maryland. The CRCR 

will design and administer the study. 

FDA is requesting OMB approval 

under the PRA for the CRCR to conduct 

research with produce growers, food 

retailers, and consumers to gain 

information about these groups’ risk 

perceptions associated with produce 

that has recently been subject to a food 

recall resulting from a foodborne illness 

outbreak. The purpose of this research 

is to help FDA better understand 

whether the magnitude and duration of 

the decline in commodity consumption 

following food recalls can be partly 

explained by grower and retailer 

speculations and projections about 

consumers’ attitudes toward food recalls 

resulting from foodborne illness 

outbreaks. This research will be used to 

assess how grower, retailer, and 

consumer perceptions, attitudes, 

knowledge, and beliefs affect market 

recovery after a hypothetical fresh 

spinach recall. 

Epidemiologists define foodborne 

illness outbreaks as two or more cases 

of a similar illness resulting from the 

ingestion of a common food (Ref. 1). 

Because many foodborne illness cases 

are mild, most outbreaks are never 

mstockstill on DSK4VPTVN1PROD with NOTICES