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
54154 Federal Register / Vol. 75, No. 171 / Friday, September 3, 2010 / Notices 

FOR FURTHER INFORMATION CONTACT: 

Regarding the guidance: Robert H. 

King, Sr., Center for Drug 

Evaluation and Research (HFD– 

003), Food and Drug 

Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 4150, 

Silver Spring, MD 20993–0002, 

301–796–1242, or 

Christopher Joneckis, Center for 

Biologics Evaluation and Research 

(HFM–25), Food and Drug 

Administration, 1401 Rockville 

Pike, suite 200N, Rockville, MD 

20852–1448, 301–827–0373. 

Regarding the ICH: Michelle Limoli, 

Office of International Programs 

(HFG–1), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827– 

4480. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In recent years, many important 

initiatives have been undertaken by 

regulatory authorities and industry 

associations to promote international 

harmonization of regulatory 

requirements. FDA has participated in 

many meetings designed to enhance 

harmonization and is committed to 

seeking scientifically based harmonized 

technical procedures for pharmaceutical 

development. One of the goals of 

harmonization is to identify and then 

reduce differences in technical 

requirements for drug development 

among regulatory agencies. 

ICH was organized to provide an 

opportunity for tripartite harmonization 

initiatives to be developed with input 

from both regulatory and industry 

representatives. FDA also seeks input 

from consumer representatives and 

others. ICH is concerned with 

harmonization of technical 

requirements for the registration of 

pharmaceutical products among three 

regions: The European Union, Japan, 

and the United States. The six ICH 

sponsors are the European Commission; 

the European Federation of 

Pharmaceutical Industries Associations; 

the Japanese Ministry of Health, Labour, 

and Welfare; the Japanese 

Pharmaceutical Manufacturers 

Association; the Centers for Drug 

Evaluation and Research and Biologics 

Evaluation and Research, FDA; and the 

Pharmaceutical Research and 

Manufacturers of America. The ICH 

Secretariat, which coordinates the 

preparation of documentation, is 

provided by the International 

Federation of Pharmaceutical 

Manufacturers Associations (IFPMA). 

The ICH Steering Committee includes 

representatives from each of the ICH 

sponsors and the IFPMA, as well as 

observers from the World Health 

Organization, Health Canada, and the 

European Free Trade Area. 

In the Federal Register of December 

17, 2009 (74 FR 66981), FDA published 

a notice announcing the availability of 

a draft tripartite guidance entitled ‘‘Q4B 

Evaluation and Recommendation of 

Pharmacopoeial Texts for Use in the 

ICH Regions; Annex 11: Capillary 

Electrophoresis General Chapter.’’ The 

notice gave interested persons an 

opportunity to submit comments by 

February 16, 2010. 

After consideration of the comments 

received and revisions to the guidance, 

a final draft guidance entitled ‘‘Q4B 

Evaluation and Recommendation of 

Pharmacopoeial Texts for Use in the 

ICH Regions; Annex 11: Capillary 

Electrophoresis General Chapter’’ was 

submitted to the ICH Steering 

Committee and endorsed by the three 

participating regulatory agencies in June 

2010. 

The guidance provides the specific 

evaluation outcome from the ICH Q4B 

process for the Capillary Electrophoresis 

General Chapter harmonization 

proposal originating from the threeparty PDG. This guidance is in the form 

of an annex to the core ICH Q4B 

guidance made available in the Federal 

Register of February 21, 2008 (73 FR 

9575). When implemented, the annex 

will provide guidance for industry and 

regulators on the use of the specific 

pharmacopoeial texts evaluated by the 

ICH Q4B process. Following receipt of 

comments on the draft, no substantive 

changes were made to the annex. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the agency’s 

current thinking on this topic. It does 

not create or confer any rights for or on 

any person and does not operate to bind 

FDA or the public. An alternative 

approach may be used if such approach 

satisfies the requirements of the 

applicable statutes and regulations. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at http:// 

www.regulations.gov, http:// 

www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm, or http:// 

www.fda.gov/BiologicsBloodVaccines/ 

GuidanceComplianceRegulatory

Information/Guidances/default.htm. 

Dated: August 30, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–21991 Filed 9–2–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2010–M–0244, FDA– 

2010–M–0220, FDA–2010–M–0219, FDA– 

2010–M–0242, FDA–2010–M–0261, FDA– 

2010–M–0262, FDA–2010–M–0264, FDA– 

2010–M–0294, FDA–2010–M–0285] 

Medical Devices; Availability of Safety 

and Effectiveness Summaries for 

Premarket Approval Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is publishing a 

list of premarket approval applications 

(PMAs) that have been approved. This 

list is intended to inform the public of 

the availability of safety and 

effectiveness summaries of approved 

PMAs through the Internet and the 

agency’s Division of Dockets 

Management. 

ADDRESSES: Submit written requests for 

copies of summaries of safety and 

effectiveness data to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

Please cite the appropriate docket 

number as listed in table 1 of this 

document when submitting a written 

request. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the summaries of safety and 

effectiveness. 

FOR FURTHER INFORMATION CONTACT: 

Nicole Wolanski, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm. 1650, Silver Spring, 

MD 20993–0002, 301–796–6570. 

SUPPLEMENTARY INFORMATION: 


srobinson on DSKHWCL6B1PROD with NOTICES