Federal Register / Vol. 72, No. 58 / Tuesday, March 27, 2007 / Notices 14279 

Washington, DC 20447, Attn: ACF 

Reports Clearance Officer. All requests 

should be identified by the title of the 

information collection. 

The Department specifically requests 

comments on: (a) Whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

the quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication. 

Dated: March 20, 2007. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 07–1481 Filed 3–26–07; 8:45 am] 

BILLING CODE 4184–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007N–0098] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Focus Groups as 

Used by the Food and Drug 

Administration 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

focus groups as used by FDA to gauge 

public opinion. 

DATES: Submit written or electronic 

comments on the collection of 

information by May 29, 2007. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to: http://www.fda.gov/ 

dockets/ecomments. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of the Chief 

Information Officer (HFA–250), Food 

and Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–827–

4659. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Focus Groups as Used by FDA (OMB 

Control Number 0910–0497)—Extension 

Focus groups provide an important 

role in gathering information because 

they allow for a more in-depth 

understanding of consumers’ attitudes, 

beliefs, motivations, and feelings than 

do quantitative studies. Focus groups 

serve the narrowly defined need for 

direct and informal opinion on a 

specific topic and as a qualitative 

research tool have three major purposes: 

• To obtain consumer information 

that is useful for developing variables 

and measures for quantitative studies, 

• To better understand consumers’

attitudes and emotions in response to 

topics and concepts, and 

• To further explore findings 

obtained from quantitative studies. 

FDA will use focus group findings to 

test and refine their ideas, but will 

generally conduct further research 

before making important decisions such 

as adopting new policies and allocating 

or redirecting significant resources to 

support these policies. 

FDA estimates the burden for 

completing the forms for this collection 

of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

FDA Center Subject 

No. of 

Focus 

Groups per 

Study 

No. of Focus 

Groups Sessions 

Conducted 

Annually 

No. of 

Participants 

per Group 

Hours of Duration for 

Each Group (Includes 

Screening) 

Total 

Hours 

Center for Biologics Evaluation and Research May use focus groups when 

appropriate 

1 5 9 1 .58 71 


sroberts on PROD1PC70 with NOTICES
14280 Federal Register / Vol. 72, No. 58 / Tuesday, March 27, 2007 / Notices 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued 

FDA Center Subject 

No. of 

Focus 

Groups per 

Study 

No. of Focus 

Groups Sessions 

Conducted 

Annually 

No. of 

Participants 

per Group 

Hours of Duration for 

Each Group (Includes 

Screening) 

Total 

Hours 

Center for Drug Evaluation and Research Varies (e.g., direct-to-consumer Rx drug promotion, 

physician labeling of Rx 

drugs, medication guides, 

over-the-counter drug labeling, risk communication) 

10 200 9 1 .58 2,844 

Center for Devices and 

Radiological Health 

Varies (e.g., FDA Seal of Approval, patient labeling, tampons, online sales of medical 

products, latex gloves) 

4 16 9 2 .08 300 

Center for Food Safety 

and Applied Nutrition 

Varies (e.g., food safety, nutrition, dietary supplements, 

and consumer education) 

8 40 9 1 .58 569 

Center for Veterinary 

Medicine 

Varies (e.g., animal nutrition, 

supplements, labeling of animal Rx) 

5 25 9 2 .08 468 

Total 28 286 9 1 .78 4,252 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Annually, FDA projects about 28 

focus group studies using 186 focus 

groups lasting an average of 1.78 hours 

each. FDA has allowed burden for 

unplanned focus groups to be 

completed so as not to restrict the 

agency’s ability to gather information on 

public sentiment for its proposals in its 

regulatory as well as other programs. 

Dated: March 16, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–5505 Filed 3–26–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2003E–0252] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; A180 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for A180 

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 

animal 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.fda.gov/dockets/ecomments. 

FOR FURTHER INFORMATION CONTACT: 

Beverly Friedman, Office of Regulatory 

Policy (HFD–7), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–594–2041. 

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 animal drug 

products, the testing phase begins on 

the earlier date when either a major 

environmental effects test was initiated 

for the drug or when an exemption 

under section 512(j) of the Federal Food, 

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

360b(j)) became effective and runs until 

the approval phase begins. The approval 

phase starts with the initial submission 

of an application to market the animal 

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 animal drug product will include all 

of the testing phase and approval phase 

as specified in 35 U.S.C. 156(g)(4)(B). 

FDA approved for marketing the 

animal drug product A180 

(danofloxacin mesylate). A180 is 

indicated for treatment of bovine 

respiratory disease associated with 

Mannheimia (Pasteurella) haemolytica 

and Pasteurella multocida in beef cattle. 

Subsequent to this approval, the Patent 

and Trademark Office received a patent 

term restoration application for A180 

(U.S. Patent No. 4,861,779) from Pfizer, 

Inc., and the Patent and Trademark 

Office requested FDA’s assistance in 

determining this patent’s eligibility for 

patent term restoration. In a letter dated 

July 16, 2003, FDA advised the Patent 

and Trademark Office that this animal 

drug product had undergone a 

regulatory review period and that the 

approval of A180 represented the first 

permitted commercial marketing or use 


sroberts on PROD1PC70 with NOTICES