52242 Federal Register / Vol. 74, No. 195 / Friday, October 9, 2009 / Notices 

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 ENTEREG 

(alvimopan). ENTEREG is a peripherally 

acting μ-opioid receptor antagonist 

indicated to accelerate the time to upper 

and lower gastrointestinal recovery 

following partial large or small bowel 

resection surgery with primary 

anastomosis. Subsequent to this 

approval, the Patent and Trademark 

Office received patent term restoration 

applications for ENTEREG (U.S. Patent 

Nos. 5,250,542 and 5,434,171) from Eli 

Lilly and Company, 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 26, 2009, FDA 

advised the Patent and Trademark 

Office that this human drug product had 

undergone a regulatory review period 

and that the approval of ENTEREG 

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 

ENTEREG is 5,305 days. Of this time, 

3,879 days occurred during the testing 

phase of the regulatory review period, 

while 1,426 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 act) (21 U.S.C. 

355(i)) became effective: November 12, 

1993. The applicant claims November 

11, 1993, as the date the investigational 

new drug application (IND) became 

effective. However, FDA records 

indicate that the IND effective date was 

November 12, 1993, which was 30 days 

after FDA receipt of the IND. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the act: June 25, 2004. FDA 

has verified the applicant’s claim that 

the new drug application (NDA) 21–775 

was submitted on June 25, 2004. 

3. The date the application was 

approved: May 20, 2008. FDA has 

verified the applicant’s claim that NDA 

21–775 was approved on May 20, 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 applications for patent extension, 

this applicant seeks 1,827 days of patent 

term extension for U.S. Patent No. 

5,250,542 and 1,826 days of patent term 

extension for U.S. Patent No. 5,434,171. 

Anyone with knowledge that any of 

the dates as published are incorrect may 

submit to the Division of Dockets 

Management (see ADDRESSES) written or 

electronic comments and ask for a 

redetermination by December 8, 2009. 

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 

April 7, 2010. 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. 

Comments and petitions should be 

submitted to the Division of Dockets 

Management. Three copies of any 

mailed information are to be submitted, 

except that individuals may submit one 

copy. Comments are to be identified 

with the docket number found in 

brackets in the heading of this 

document. Comments and petitions may 

be seen in the Division of Dockets 

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

Monday through Friday. 

Dated: August 31, 2009. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. E9–24457 Filed 10–8–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0448] 

Draft Guidance for Industry and Food 

and Drug Administration Staff; the 

Mammography Quality Standards Act 

Final Regulations: Modifications and 

Additions to Policy Guidance Help 

System #13; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the draft guidance 

entitled ‘‘The Mammography Quality 

Standards Act Final Regulations: 

Modifications and Additions to Policy 

Guidance Help System #13.’’ This 

document is intended to provide 

guidance to mammography facilities 

and their personnel. It represents FDA’s 

current thinking on the final regulations 

implementing the Mammography 

Quality Standards Act of 1992 (MQSA). 

This guidance document updates 

previous guidance. This draft guidance 

is not final nor is it in effect at this time. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

written or electronic comments on the 

draft guidance by January 7, 2010. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance 

document entitled ‘‘The Mammography 

Quality Standards Act Final 

Regulations: Modifications and 

Additions to Policy Guidance Help 

System #13’’ 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. Send 

one self-addressed adhesive label to 

assist that office in processing your 

request, or fax your request to 301–847– 

8149. See the SUPPLEMENTARY

INFORMATION section for information on 

electronic access to the guidance. 

Submit written comments concerning 

this draft guidance to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

Submit electronic comments to http:// 

www.regulations.gov. Identify 

comments with the docket number 

mstockstill on DSKH9S0YB1PROD with NOTICES

Federal Register / Vol. 74, No. 195 / Friday, October 9, 2009 / Notices 52243 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Charles Finder, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm. 4646, Silver Spring, 

MD 20993–0002, 301–796–5715. 

SUPPLEMENTARY INFORMATION: 

I. Background 

MQSA (Pub. L. 102–539) was signed 

into law on October 27, 1992, to 

establish national quality standards for 

mammography. It is codified at 42 

U.S.C. 263b. The MQSA requires that, in 

order to lawfully provide 

mammography services after October 1, 

1994, all facilities, except facilities of 

the Department of Veterans Affairs, 

must be accredited by an approved 

accreditation body and certified by the 

Secretary of Health and Human Services 

(the Secretary) or by an approved State 

certification agency (section 354(b) of 

the MQSA; 42 U.S.C. 263b(b)). In June 

1993, the authority to approve 

accreditation bodies and State 

certification agencies and to certify 

facilities was delegated by the Secretary 

to the FDA (58 FR 32543). On October 

28, 1997, the FDA first published final 

regulations implementing the MQSA in 

the Federal Register (21 CFR part 900) 

(62 FR 55852). The MQSA has twice 

been amended since its enactment, 

through the Mammography Quality 

Standards Reauthorization Acts 

(MQSRA) of 1998 and 2004 (Pub. L. 

105–248 and Pub. L. 108–365). 

This draft guidance updates the 

Policy Guidance Help System and 

addresses or contains the following: 

1. Updated contact information for 

accreditation bodies and certification 

agencies; 

2. General guidance regarding 

Additional Mammography Reviews 

(AMRs); 

3. Previously approved alternative 

standards; 

4. Centers for Medicare and Medicaid 

Services (CMS) reimbursement; 

5. Mechanisms to inform physicians 

and patients of mammography results; 

6. Labeling of mammographic images; 

7. Mammographic modality and its 

impact on personnel experience 

requirements; 

8. Clarification of the personnel 6- 

month exemption period; 

9. Information on calibrating the air 

kerma measuring instrument; 

10. Medical physicist involvement as 

it applies to cassette replacement; 

11. Full Field Digital Mammography 

(FFDM) and use of single-use cushion 

pads; 

12. Quality control testing of 

computer controlled compression 

devices; 

13. Mammography equipment 

evaluations of laser printers; 

14. Quality control testing of monitors 

and laser printers; 

15. Mammography equipment 

evaluations of new FFDM units; and 

16. Mammography equipment 

evaluations of off-site laser printers and 

monitors. 

In November 1998, FDA compiled all 

to-date final FDA guidances related to 

MQSA and put them into a 

computerized searchable database 

called the Policy Guidance Help System 

(PGHS). The PGHS is available on the 

Internet at http://www.fda.gov/cdrh/ 

mammography/robohelp/start.htm. 

FDA periodically updates the 

information in the PGHS, and this 

document serves as a further update. 

Individuals wishing to receive 

automatic notification of future updates 

may subscribe to our e-mail ListServ by 

visiting http://service.govdelivery.com/ 

service/subscribe.html?code=USFDA_45 

and following the directions there. 

II. Significance of Guidance 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the agency’s current thinking 

on ‘‘The Mammography Quality 

Standards Act Final Regulations: 

Modifications and Additions to Policy 

Guidance Help System #13.’’ 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 draft guidance may do so by using 

the Internet. To receive ‘‘The 

Mammography Quality Standards Act 

Final Regulations: Modifications and 

Additions to Policy Guidance Help 

System #13,’’ 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– 

847–8149 to receive a hard copy. Please 

use the document number (1695) to 

identify the guidance you are 

requesting. 

CDRH maintains an entry on the 

Internet for easy access to information 

including text, graphics, and files that 

may be downloaded to a personal 

computer with Internet access. Updated 

on a regular basis, the CDRH home page 

includes device safety alerts, Federal 

Register reprints, information on 

premarket submissions (including lists 

of approved applications and 

manufacturers’ addresses), small 

manufacturers’ assistance, information 

on video conferencing and electronic 

submissions, Mammography Matters, 

and other device-oriented information. 

The CDRH web site may be accessed at 

http://www.fda.gov/cdrh. A search 

capability for all CDRH guidance 

documents is available at http:// 

www.fda.gov/cdrh/guidance.html. 

Guidance documents are also available 

at http://www.regulations.gov. 

IV. Paperwork Reduction Act 

This draft guidance refers to 

previously approved collections of 

information found in FDA regulations. 

These collections of information 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 collections 

of information in 21 CFR part 900 have 

been approved under OMB Control No. 

0910–0309. 

V. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES), written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified 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: October 1, 2009. 

Jeffrey Shuren, 

Acting Director, Center for Devices and 

Radiological Health. 

[FR Doc. E9–24435 Filed 10–8–09; 8:45 am] 

BILLING CODE 4160–01–S 

mstockstill on DSKH9S0YB1PROD with NOTICES