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
Federal Register / Vol. 75, No. 171 / Friday, September 3, 2010 / Notices 54153 

FDA recently approved for marketing 

the medical device, NEURX 

DIAPHRAGM PACING SYSTEM. 

NEURX DIAPHRAGM PACING 

SYSTEM is indicated to allow patients 

with stable, high spinal cord injuries 

and with stimulatable diaphragms to 

breathe without the assistance of a 

mechanical ventilator for at lease 4 

continuous hours a day. Subsequent to 

this approval, the Patent and Trademark 

Office received a patent term restoration 

application for NEURX DIAPHRAGM 

PACING SYSTEM (U.S. Patent No. 

5,472,438) from Case Western Reserve 

University, and the Patent and 

Trademark Office requested FDA’s 

assistance in determining this patent’s 

eligibility for patent term restoration. In 

a letter dated February 17, 2010, FDA 

advised the Patent and Trademark 

Office that this medical device had 

undergone a regulatory review period 

and that the approval of NEURX 

DIAPHRAGM PACING SYSTEM 

represented the first permitted 

commercial marketing or use of the 

product. Thereafter, the Patent and 

Trademark Office requested that the 

FDA determine the product’s regulatory 

review period. 

FDA has determined that the 

applicable regulatory review period for 

NEURX DIAPHRAGM PACING 

SYSTEM is 5,166 days. Of this time, 

4,830 days occurred during the testing 

phase of the regulatory review period, 

while 336 days occurred during the 

approval phase. These periods of time 

were derived from the following dates: 

1. The date an exemption under 

section 520(g) of the Federal Food, Drug, 

and Cosmetic Act (the act) (21 U.S.C. 

360j(g)) involving this device became 

effective: April 28, 1994. FDA has 

verified the applicant’s claim that the 

date the investigational device 

exemption (IDE) required under section 

520(g) of the act for human tests to begin 

became effective April 28, 1994. 

2. The date an application was 

initially submitted with respect to the 

device under section 515 of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

360e): July 18, 2007. FDA has verified 

the applicant’s claim that the premarket 

approval application (PMA) for NEURX 

DIAPHRAGM PACING SYSTEM (PMA 

H070003) was initially submitted July 

18, 2007. 

3. The date the application was 

approved: June 17, 2008. FDA has 

verified the applicant’s claim that PMA 

H070003 was approved on June 17, 

2008. 

This determination of the regulatory 

review period establishes the maximum 

potential length of a patent extension. 

However, the U.S. Patent and 

Trademark Office applies several 

statutory limitations in its calculations 

of the actual period for patent extension. 

In its application for patent extension, 

this applicant seeks 1,737 days of patent 

term extension. 

Anyone with knowledge that any of 

the dates as published are incorrect may 

submit to the Division of Dockets 

Management (see ADDRESSES) either 

electronic or written comments and ask 

for a redetermination by November 2, 

2010. Furthermore, any interested 

person may petition FDA for a 

determination regarding whether the 

applicant for extension acted with due 

diligence during the regulatory review 

period by March 2, 2011. To meet its 

burden, the petition must contain 

sufficient facts to merit an FDA 

investigation. (See H. Rept. 857, part 1, 

98th Cong., 2d sess., pp. 41–42, 1984.) 

Petitions should be in the format 

specified in 21 CFR 10.30. 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) electronic or written 

comments and written petitions. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send three copies of mailed comments. 

However, if you submit a written 

petition, you must submit three copies 

of the petition. Identify comments with 

the docket number found in brackets in 

the heading of this document. 

Comments and petitions that have not 

been made publicly available on 

regulations.gov may be viewed in the 

Division of Dockets Management 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

Dated: August 13, 2010. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. 2010–22081 Filed 9–2–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0579] 

International Conference on 

Harmonisation; Guidance on Q4B 

Evaluation and Recommendation of 

Pharmacopoeial Texts for Use in the 

International Conference on 

Harmonisation Regions; Annex 11 on 

Capillary Electrophoresis General 

Chapter; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance entitled ‘‘Q4B 

Evaluation and Recommendation of 

Pharmacopoeial Texts for Use in the 

ICH Regions; Annex 11: Capillary 

Electrophoresis General Chapter.’’ The 

guidance was prepared under the 

auspices of the International Conference 

on Harmonisation of Technical 

Requirements for Registration of 

Pharmaceuticals for Human Use (ICH). 

The guidance provides the results of the 

ICH Q4B evaluation of the Capillary 

Electrophoresis General Chapter 

harmonized text from each of the three 

pharmacopoeias (United States, 

European, and Japanese) represented by 

the Pharmacopoeial Discussion Group 

(PDG). The guidance conveys 

recognition of the three pharmacopoeial 

methods by the three ICH regulatory 

regions and provides specific 

information regarding the recognition. 

The guidance is intended to recognize 

the interchangeability between the local 

regional pharmacopoeias, thus avoiding 

redundant testing in favor of a common 

testing strategy in each regulatory 

region. This guidance is in the form of 

an annex to the core guidance on the 

Q4B process entitled ‘‘Q4B Evaluation 

and Recommendation of 

Pharmacopoeial Texts for Use in the 

ICH Regions’’ (the core ICH Q4B 

guidance). 

DATES: Submit either electronic or 

written comments on agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Division of Drug Information (HFD– 

240), Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, rm. 2201, Silver Spring, 

MD 20993–0002, or the Office of 

Communication, Outreach and 

Development (HFM–40), Center for 

Biologics Evaluation and Research 

(CBER), Food and Drug Administration, 

1401 Rockville Pike, suite 200N, 

Rockville, MD 20852–1448. Send one 

self-addressed adhesive label to assist 

the office in processing your requests. 

The guidance may also be obtained by 

mail by calling CBER at 1–800–835– 

4709 or 301–827–1800. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the guidance 

document. 

Submit electronic comments on the 

guidance to http://www.regulations.gov. 

Submit written comments to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 


srobinson on DSKHWCL6B1PROD with NOTICES