Federal Register / Vol. 75, No. 171 / Friday, September 3, 2010 / Notices 54151 

Hours: 6,000 (For policy questions 

regarding this collection contact Diane 

Ross at 410–786–1169. For all other 

issues call 410–786–1326.) 

4. Type of Information Collection 

Request: Reinstatement with change of a 

previously approved collection; Title of 

Information Collection: Beneficiary 

Customer Service Feedback Survey; 

Use: The Centers for Medicare and 

Medicaid Services (CMS) stresses a 

continuing need for setting customer 

service goals that include providing 

accurate, timely, and relevant 

information to its customers. With these 

goals in mind, the Division of Medicare 

Ombudsman Assistance (DMOA) needs 

to periodically survey its customers that 

correspond with CMS to ensure that the 

needs of Medicare beneficiaries are 

being met. This survey will be used to 

measure overall satisfaction of the 

customer service that the DMOA 

provides to Medicare beneficiaries and 

their representatives. The need for this 

previously OMB approved information 

collection is to further meet the 

customer service goals that the CMS has 

established and to continue to create a 

rapport within the Medicare 

community. Form Number: CMS–10068 

(OMB#: 0938–0894); Frequency: 

Quarterly; Affected Public: Individuals 

and Households; Number of 

Respondents: 2,242 Total Annual 

Responses: 2,242; Total Annual Hours: 

224. (For policy questions regarding this 

collection contact Nancy Conn at 410– 

786–8374. For all other issues call 410– 

786–1326.) 

5. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: End Stage Renal 

Disease Medical Evidence Report 

Medicare Entitlement and/or Patient 

Registration; Use: The End Stage Renal 

Disease (ESRD) Medical Evidence 

Report is completed for all ESRD 

patients either by the first treatment 

facility or by a Medicare-approved 

ESRD facility when it is determined by 

a physician that the patient’s condition 

has reached that stage of renal 

impairment that a regular course of 

kidney dialysis or a kidney transplant is 

necessary to maintain life. The data 

reported on the CMS–2728 is used by 

the Federal Government, ESRD 

Networks, treatment facilities, 

researchers and others to monitor and 

assess the quality and type of care 

provided to end stage renal disease 

beneficiaries. The data collection 

captures the specific medical 

information required to determine the 

Medicare medical eligibility of End 

Stage Renal Disease claimants. Form 

Number: CMS–2728 (OMB#: 0938– 

0046); Frequency: Occasionally; 

Affected Public: Individuals or 

households; Number of Respondents: 

100,000; Total Annual Responses: 

100,000; Total Annual Hours: 75,000. 

(For policy questions regarding this 

collection contact Connie Cole at 410– 

786–0257. For all other issues call 410– 

786–1326.) 

6. Type of Information Collection 

Request: Reinstatement with change of a 

previously approved collection; Title of 

Information Collection: Conditions of 

Coverage for Organ Procurement 

Organizations and Supporting 

Regulations in 42 CFR, Sections 

486.301–.348; Use: Section 1138(b) of 

the Social Security Act, as added by 

section 9318 of the Omnibus Budget 

Reconciliation Act of 1986 (Pub. L. 99– 

509), sets forth the statutory 

qualifications and requirements that 

OPOs must meet in order for the costs 

of their services in procuring organs for 

transplant centers to be reimbursable 

under the Medicare and Medicaid 

programs. An OPO must be certified and 

designated by the Secretary as an OPO 

and must meet performance-related 

standards prescribed by the Secretary. 

The corresponding regulations are 

found at 42 CFR Part 486 (Conditions 

for Coverage of Specialized Services 

Furnished by Suppliers) under subpart 

G (Requirements for Certification and 

Designation and Conditions for 

Coverage: Organ Procurement 

Organizations). 

Since each OPO has a monopoly on 

organ procurement within its donation 

service area, CMS must hold OPOs to 

high standards. Collection of this 

information is necessary for CMS to 

assess the effectiveness of each OPO and 

determine whether it should continue to 

be certified as an OPO and designated 

for a particular donation service area by 

the Secretary or replaced by an OPO 

that can more effectively procure organs 

within the donation service area. Form 

Number: CMS–R–13 (OMB#: 0938– 

0688); Frequency: Occasionally; 

Affected Public: Not-for-profit 

institutions; Number of Respondents: 

79; Total Annual Responses: 79; Total 

Annual Hours: 15,178. (For policy 

questions regarding this collection 

contact Diane Corning at 410–786–8486. 

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 

address 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. 

To be assured consideration, 

comments and recommendations for the 

proposed information collections must 

be received by the OMB desk officer at 

the address below, no later than 5 p.m. 

on October 4, 2010. 

OMB, Office of Information and 

Regulatory Affairs, Attention: CMS 

Desk Officer, Fax Number: (202) 395– 

6974, E-mail: 

OIRA_submission@omb.eop.gov. 

Dated: August 26, 2010. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2010–21721 Filed 9–2–10; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day–10–10GX] 

Proposed Data Collections Submitted 

for Public Comment and 

Recommendations 

In compliance with the requirement 

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

Paperwork Reduction Act of 1995 for 

opportunity for public comment on 

proposed data collection projects, the 

Centers for Disease Control and 

Prevention (CDC) will publish periodic 

summaries of proposed projects. To 

request more information on the 

proposed projects or to obtain a copy of 

the data collection plans and 

instruments, call 404–639–5960 and 

send comments to Maryam I. Daneshvar, 

Ph.D., CDC Reports Clearance Officer, 

1600 Clifton Road, MS–D74, Atlanta, 

GA 30333 or send an e-mail to 

omb@cdc.gov. 

Comments are invited on: (a) Whether 

the proposed collection of information 

is necessary for the proper performance 

of the functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. Written comments should 

be received within 60 days of this 

notice. 


srobinson on DSKHWCL6B1PROD with NOTICES
54152 Federal Register / Vol. 75, No. 171 / Friday, September 3, 2010 / Notices 

Proposed Project 

Persistence of Viable Influenza Virus 

in Aerosols—New—National Institute 

for Occupational Safety and Health 

(NIOSH), Centers for Disease Control 

and Prevention (CDC). 

Background and Brief Description 

The National Institute for 

Occupational Safety and Health 

(NIOSH) is authorized to conduct 

research to advance the health and 

safety of workers under Section 20(a)(1) 

of the 1970 Occupational Safety and 

Health Act. 

Influenza continues to be a major 

public health concern because of the 

substantial health burden from seasonal 

influenza and the potential for a severe 

pandemic. Although influenza is known 

to be transmitted by infectious 

secretions, these secretions can be 

transferred from person to person in 

many different ways, and the relative 

importance of the different pathways is 

not known. The likelihood of the 

transmission of influenza virus by small 

infectious airborne particles produced 

during coughing and breathing is 

particularly unclear. The question of 

airborne transmission is especially 

important in healthcare facilities, where 

influenza patients tend to congregate 

during influenza season, because it 

directly impacts the infection control 

and personal protective measures that 

should be taken by healthcare workers. 

The purpose of this study is to 

measure the amount of viable influenza 

virus in airborne particles that are 

produced by patients when they cough, 

and the size and quantity of the 

particles carrying the virus. A better 

understanding of the amount of 

potentially infectious material released 

by patients and the size of the particles 

carrying the virus will assist in 

determining the possible role of 

airborne transmission in the spread of 

influenza and in devising measures to 

prevent it. 

Volunteer participants will be 

recruited by a test coordinator using a 

flyer describing the study. Interested 

potential participants will be screened 

using a short health questionnaire to 

verify that they have influenza-like 

symptoms and that they do not have any 

medical conditions that would preclude 

their participation. Qualified 

participants who agree to participate in 

the study will be asked to read and sign 

an informed consent form. Based on a 

previous study using similar forms, we 

estimate that the health questionnaire 

will require about 5 minutes to 

complete, and the informed consent 

form will take about 20 minutes to read 

and sign. Once the informed consent 

form is signed, the participant will be 

asked to cough into an aerosol particle 

collection system, and the airborne 

particles produced by the participant 

during coughing will be collected and 

tested. 

ESTIMATED ANNUAL BURDEN HOURS

Type of 

respondent Form Number of respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

Initial participants .............................. Health questionnaire ........................ 132 1 5/60 11 

Qualified participants ........................ Informed Consent form .................... 120 1 20/60 40 

Total ........................................... ........................................................... ........................ ........................ ........................ 51 

Dated: August 27, 2010. 

Maryam I. Daneshvar, 

Reports Clearance Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. 2010–22053 Filed 9–2–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–E–0290] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; NEURX DIAPHRAGM 

PACING SYSTEM 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for NEURX 

DIAPHRAGM PACING SYSTEM and is 

publishing this notice of that 

determination as required by law. FDA 

has made the determination because of 

the submission of an application to the 

Director of Patents and Trademarks, 

Department of Commerce, for the 

extension of a patent which claims that 

medical device. 

ADDRESSES: Submit electronic 

comments to http:// 

www.regulations.gov. Submit written 

petitions along with three copies and 

written comments to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Beverly Friedman, Office of Regulatory 

Policy, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 51, 

rm. 6222, Silver Spring, MD 20993– 

0002, 301–796–3602. 

SUPPLEMENTARY INFORMATION: The Drug 

Price Competition and Patent Term 

Restoration Act of 1984 (Public Law 98– 

417) and the Generic Animal Drug and 

Patent Term Restoration Act (Public 

Law 100–670) generally provide that a 

patent may be extended for a period of 

up to 5 years so long as the patented 

item (human drug product, animal drug 

product, medical device, food additive, 

or color additive) was subject to 

regulatory review by FDA before the 

item was marketed. Under these acts, a 

product’s regulatory review period 

forms the basis for determining the 

amount of extension an applicant may 

receive. 

A regulatory review period consists of 

two periods of time: A testing phase and 

an approval phase. For medical devices, 

the testing phase begins with a clinical 

investigation of the device and runs 

until the approval phase begins. The 

approval phase starts with the initial 

submission of an application to market 

the device and continues until 

permission to market the device is 

granted. Although only a portion of a 

regulatory review period may count 

toward the actual amount of extension 

that the Director of Patents and 

Trademarks may award (half the testing 

phase must be subtracted as well as any 

time that may have occurred before the 

patent was issued), FDA’s determination 

of the length of a regulatory review 

period for a medical device will include 

all of the testing phase and approval 

phase as specified in 35 U.S.C. 

156(g)(3)(B). 


srobinson on DSKHWCL6B1PROD with NOTICES