Federal Register / Vol. 74, No. 195 / Friday, October 9, 2009 / Notices 52241 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN—Continued 

Form name Number of 

respondents 

Total burden 

hours 

Average hourly wage rate* Total cost 

burden 

Institutions (non-hospital) questionnaire .......................................................... 72 9 14.24 128 

Pharmacies questionnaire ............................................................................... 7,760 9,040 14.24 128,730 

Subtotal for the MEPS–MPC .................................................................... 39,813 20,077 na 285,965 

Grand Total ....................................................................................... 92,613 82,767 na 1,512,181 

*Based upon the mean of the average 

wages for Healthcare Support Workers, All 

Other (31–9099) and All Occupations (00– 

0000), Occupational Employment Statistics, 

May 2007 National Occupational 

Employment and Wage Estimates United 

States, U.S. Department of Labor, Bureau of 

Labor Statistics. http://www.bls.gov/oes/ 

current/oes_nat.htm#b29–0000. 

Estimated Annual Costs to the Federal 

Government 

Exhibit 3 shows the total and 

annualized cost of this information 

collection. The cost associated with the 

design and data collection of the MEPS– 

HC and MEPS–MPC is estimated to be 

$47.6 million in each of the next three 

fiscal years. 

EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST

Cost Component Total cost 

(millions) 

Annualized 

cost 

(millions) 

Sampling Activities ................................................................................................................................................... $2.79 $0.93 

Interviewer Recruitment and Training ..................................................................................................................... 8.52 2.84 

Data Collection Activities ......................................................................................................................................... 86.7 28.9 

Data Processing ...................................................................................................................................................... 21.39 7.13 

Production of Public Use Data Files ....................................................................................................................... 19.53 6.51 

Project Management ................................................................................................................................................ 3.93 1.31 

Total .................................................................................................................................................................. 142.8 47.6 

Request for Comments 

In accordance with the above-cited 

Paperwork Reduction Act legislation, 

comments on AHRQ’s information 

collection are requested with regard to 

any of the following: (a) Whether the 

proposed collection of information is 

necessary for the proper performance of 

AHRQ health care research and health 

care information dissemination 

functions, including whether the 

information will have practical utility; 

(b) the accuracy of AHRQ’s estimate of 

burden (including hours and costs) of 

the proposed collection(s) 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 upon the 

respondents, including the use of 

automated collection techniques or 

other forms of information technology. 

Comments submitted in response to 

this notice will be summarized and 

included in the Agency’s subsequent 

request for 0MB approval of the 

proposed information collection. All 

comments will become a matter of 

public record. 

Dated: September 16, 2009. 

Carol M. Clancy, 

Director. 

[FR Doc. E9–24305 Filed 10–8–09; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2009–E–0073 and FDA– 

2009–E–0015] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; ENTEREG; U.S. Patent Nos. 

5,250,542 and 5,434,171 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

ENTEREG 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 written comments 

and petitions 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. 

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 human drug 

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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 

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