20826 Federal Register / Vol. 77, No. 67 / Friday, April 6, 2012 / Notices 

Dated: March 29, 2012. 

Nancy K. Stade, 

Deputy Director for Policy, Center for Devices 

and Radiological Health. 

[FR Doc. 2012–8227 Filed 4–5–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0153] 

Guidance for Industry and Food and 

Drug Administration Staff; Food and 

Drug Administration and Industry 

Procedures for Section 513(g) 

Requests for Information Under the 

Federal Food, Drug, and Cosmetic Act; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the guidance entitled 

‘‘Guidance for Industry and Food and 

Drug Administration Staff; FDA and 

Industry Procedures for Section 513(g) 

Requests for Information under the 

Federal Food, Drug, and Cosmetic Act.’’ 

This guidance document establishes the 

procedures for the submission, FDA 

review, and FDA response to requests 

for information regarding the class in 

which a device has been classified. 

DATES: Submit either electronic or 

written comments on this guidance at 

any time. General comments on Agency 

guidance documents are welcome at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the guidance document 

entitled ‘‘Guidance for Industry and 

Food and Drug Administration Staff; 

FDA and Industry Procedures for 

Section 513(g) Requests for Information 

under the Federal Food, Drug, and 

Cosmetic Act’’ to the Division of Small 

Manufacturers, International and 

Consumer Assistance, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, rm. 4613, 

Silver Spring, MD 20993–0002 or Office 

of Communication, Outreach and 

Development (HFM–40), 1401 Rockville 

Pike, suite 200N, Rockville, MD 20852. 

Send one self-addressed adhesive label 

to assist that office in processing your 

request, or fax your request to 301–847– 

8419. See the SUPPLEMENTARY

INFORMATION section for information on 

electronic access to the guidance. 

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. Identify comments with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Bob Gatling, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New 

Hampshire Ave., Bldg. 66, rm. 1640, 

Silver Spring, MD 20993–0002, 301– 

796–6560; or 

Stephen Ripley, Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration, 1401 

Rockville Pike, suite 200N, Rockville, 

MD 20852, 301–827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 513(g) of the Federal Food, 

Drug, and Cosmetic Act (the FD&C Act) 

(21 U.S.C. 360c(g)) provides a means for 

obtaining FDA’s views about the 

classification and the regulatory 

requirements that may be applicable to 

a particular device. This guidance 

describes procedures for the 

submission, FDA review, and FDA 

response to requests for information 

with respect to the classification of a 

device or the requirements applicable to 

a device under the FD&C Act that are 

submitted in accordance with section 

513(g) requests for information. FDA’s 

response to section 513(g) requests for 

information are not device classification 

decisions and do not constitute FDA 

clearance or approval for marketing. 

Classification decisions and clearance or 

approval for marketing require 

submissions under different sections of 

the FD&C Act. 

In the Federal Register of April 29, 

2010 (75 FR 22599), FDA announced the 

availability of the draft guidance. 

Comments on the draft guidance were 

due by July 28, 2010. No comments 

were received. The guidance announced 

in this notice finalizes the draft 

guidance of the same title. 

Additionally, the FD&C Act, as 

amended by the FDA Amendments Act 

of 2007 (FDAAA) (Pub. L. 110–85), 

requires FDA to collect user fees for 

section 513(g) requests for information. 

Elsewhere in this issue of the Federal 

Register, FDA is publishing a document 

announcing the availability of a 

guidance entitled ‘‘Guidance for 

Industry and Food and Drug 

Administration Staff; User Fees for 

513(g) Requests for Information.’’ 

II. Significance of Guidance 

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 procedures 

regarding section 513(g) requests. 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 statute and regulations. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the guidance may do so by using the 

Internet. A search capability for all 

CDRH guidance documents is available 

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

DeviceRegulationandGuidance/ 

GuidanceDocuments/default.htm. 

Guidance documents are also available 

at http://www.regulations.gov or from 

the CBER Internet site at http:// 

www.fda.gov/BiologicsBloodVaccines/

GuidanceCompliance

RegulatoryInformation/default.htm. To 

receive ‘‘Guidance for Industry and 

Food and Drug Administration Staff; 

FDA and Industry Procedures for 

Section 513(g) Requests for Information 

under the Federal Food, Drug, and 

Cosmetic Act,’’ you may either send an 

email request to dsmica@fda.hhs.gov to 

receive an electronic copy of the 

document or send a fax request to 301– 

847–8419 to receive a hard copy. Please 

use the document number 1671 to 

identify the guidance you are 

requesting. 

IV. Paperwork Reduction Act of 1995 

This guidance contains information 

collection provisions that are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). The collection(s) of information 

in this guidance was approved under 

OMB control number 0910–0705. 

This guidance also refers to currently 

approved collections of information 

found in FDA regulations. The 

collections of information in 21 CFR 

part 807 subpart E have been approved 

under OMB control number 0910–0120; 

the collections of information in 21 CFR 

part 814 have been approved under 

OMB control number 0910–0231; the 

collections of information in 21 CFR 

part 801 have been approved under 

OMB control number 0910–0485; and 

the collections of information in 21 CFR 

860.123 have been approved under 

OMB control number 0910–0138. 

V. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES), either electronic or written 

comments regarding this document. It is 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 77, No. 67 / Friday, April 6, 2012 / Notices 20827 

only necessary to send one set of 

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. 

Dated: March 29, 2012. 

Nancy K. Stade, 

Deputy Director for Policy, Center for Devices 

and Radiological Health. 

[FR Doc. 2012–8226 Filed 4–5–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2011–E–0245 and FDA– 

2011–E–0246] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; TEFLARO 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

TEFLARO and is publishing this notice 

of that determination as required by 

law. FDA has made the determination 

because of the submission of 

applications to the Director of Patents 

and Trademarks, Department of 

Commerce, for the extension of patents 

which claim that human drug product. 

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 (Pub. L. 98–417) 

and the Generic Animal Drug and Patent 

Term Restoration Act (Pub. L. 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 human drug 

products, the testing phase begins when 

the exemption to permit the clinical 

investigations of the drug becomes 

effective and runs until the approval 

phase begins. The approval phase starts 

with the initial submission of an 

application to market the human drug 

product and continues until FDA grants 

permission to market the drug product. 

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 (for example, 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 human drug product will 

include all of the testing phase and 

approval phase as specified in 35 U.S.C. 

156(g)(1)(B). 

FDA recently approved for marketing 

the human drug product TEFLARO 

(ceftaroline fosamil). TEFLARO is 

indicated for the treatment of the 

following infections caused by 

designated susceptible bacteria: Acute 

bacterial skin and skin structure 

infections; and community-acquired 

bacterial pneumonia. Subsequent to this 

approval, the Patent and Trademark 

Office received patent term restoration 

applications for TEFLARO (U.S. Patent 

Nos. 6,417,175 and 6,906,055) from 

Takeda Pharmaceutical Company 

Limited, and the Patent and Trademark 

Office requested FDA’s assistance in 

determining the patents’ eligibility for 

patent term restoration. In a letter dated 

June 8, 2011, FDA advised the Patent 

and Trademark Office that this human 

drug product had undergone a 

regulatory review period and that the 

approval of TEFLARO represented the 

first permitted commercial marketing or 

use of the product. Thereafter, the 

Patent and Trademark Office requested 

that FDA determine the product’s 

regulatory review period. 

FDA has determined that the 

applicable regulatory review period for 

TEFLARO is 2,118 days. Of this time, 

1,814 days occurred during the testing 

phase of the regulatory review period, 

while 304 days occurred during the 

approval phase. These periods of time 

were derived from the following dates: 

1. The date an exemption under 

section 505(i) of the Federal Food, Drug, 

and Cosmetic Act (the FD&C Act) (21 

U.S.C. 355(i)) became effective: January 

12, 2005. FDA has verified the 

applicant’s claim that the date the 

investigational new drug application 

became effective was on January 12, 

2005. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the FD&C Act: December 30, 

2009. FDA has verified the applicant’s 

claim that the new drug application 

(NDA) for TEFLARO (NDA 200–327) 

was submitted on December 30, 2009. 

3. The date the application was 

approved: October 29, 2010. FDA has 

verified the applicant’s claim that NDA 

200–327 was approved on October 29, 

2010. 

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 applications for patent extension, 

this applicant seeks 1,049 days or 1,211 

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 June 5, 2012. 

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 

October 3, 2012. 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. 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: March 19, 2012. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. 2012–8339 Filed 4–5–12; 8:45 am] 

BILLING CODE 4160–01–P 

mstockstill on DSK4VPTVN1PROD with NOTICES