Federal Register / Vol. 74, No. 108 / Monday, June 8, 2009 / Notices 27145 

disease, disability, and death. The 

NTCP’s four goal areas are: (1) The 

prevention of initiation of tobacco use 

among young people, (2) the elimination 

of nonsmokers’ exposure to secondhand 

smoke, (3) the promotion of quitting 

among adults and young people, and 

(4) the elimination of tobacco-related 

disparities. 

CDC proposes to conduct the National 

Adult Tobacco Survey (NATS) in order 

to collect essential information on key 

indicators of the effectiveness for the 

NTCP. The NATS will be a one-time, 

stratified, random-digit dialed telephone 

survey of non-institutionalized adults 

18 years of age and older. In order to 

yield results that are representative and 

comparable at both national and state 

levels, information will be collected 

from 3,000 respondents per state and 

the District of Columbia. In addition, a 

total of approximately 3,000 interviews 

will be conducted specifically from a 

national sample of cell phone users in 

an attempt to include the growing 

population of households that 

exclusively use cell phones and would 

be missed in a survey relying only on 

land-lines. 

Information collected through the 

NATS will be used to: (1) Generate 

state-level estimates of tobacco use for 

males and females, (2) generate statelevel estimates of tobacco use for 

minority groups comprising a major 

component of a given state’s population, 

(3) develop estimates of tobacco use at 

the national level by gender and race/ 

ethnicity, and (4) support the evaluation 

of comprehensive state-based Tobacco 

Control Programs using key outcome 

indicators at the state and national 

levels. Study results will have 

significant implications for the 

development of policies and programs 

aimed at preventing or reducing tobacco 

use. There are no costs to respondents 

except their time. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

Adults ages 18 or older .................... National Adult Tobacco Survey ....... 156,000 1 22/60 57,200 

Dated: June 1, 2009. 

Maryam I. Daneshvar, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. E9–13301 Filed 6–5–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0251] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; User Fee Cover 

Sheet; Form FDA 3397 

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 

Form FDA 3397, User Fee Cover Sheet, 

that must be submitted along with 

certain drug and biologic product 

applications and supplements. 

DATES: Submit written or electronic 

comments on the collection of 

information by August 7, 2009. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. 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 Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3794. 

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 

comment 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. 

User Fee Cover Sheet; Form FDA 

3397—(OMB Control Number 0910– 

0297)—Extension 

Under sections 735 and 736 of the 

Federal Food, Drug, and Cosmetic Act 

(the FD&C Act) (21 U.S.C. 379g and 

379h), the Prescription Drug User Fee 

Act of 1992 (PDUFA) (Public Law 102– 

571), as amended by the Food and Drug 

Administration Modernization Act of 

1997 (Public Law 105–115), the Public 

Health Security and Bioterrorism 

Preparedness and Response Act of 2002, 

which includes the Prescription Drug 

User Fee Amendments of 2002 (Public 

Law 107–188), and most recently by the 

Food and Drug Administration 


cprice-sewell on PRODPC61 with NOTICES
27146 Federal Register / Vol. 74, No. 108 / Monday, June 8, 2009 / Notices 

Amendments Act of 2007 (Public Law 

110–85), FDA has the authority to assess 

and collect user fees for certain drug 

and biologics license applications and 

supplements. Under this authority, 

pharmaceutical companies pay a fee for 

certain new human drug applications, 

biologics license applications, or 

supplements submitted to the agency for 

review. Because the submission of user 

fees concurrently with applications and 

supplements is required, review of an 

application by FDA cannot begin until 

the fee is submitted. Form FDA 3397, 

the user fee cover sheet, is designed to 

provide the minimum necessary 

information to determine whether a fee 

is required for review of an application, 

to determine the amount of the fee 

required, and to account for and track 

user fees. The form provides a crossreference of the fee submitted for an 

application by using a unique number 

tracking system. The information 

collected is used by FDA’s Center for 

Drug Evaluation and Research (CDER) 

and Center for Biologics Evaluation and 

Research (CBER) to initiate the 

administrative screening of new drug 

applications, biologics license 

applications, and supplemental 

applications. 

Respondents to this collection of 

information are new drug and biologics 

manufacturers. Based on FDA’s database 

system for fiscal year (FY) 2008, there 

are an estimated 255 manufacturers of 

products subject to the user fee 

provisions of PDUFA. However, not all 

manufacturers will have any 

submissions, and some may have 

multiple submissions in a given year. 

The total number of annual responses is 

based on the number of submissions 

received by FDA in FY 2008. CDER 

received 3,107 annual responses that 

include the following submissions: 147 

new drug applications; 13 biologics 

license applications; 1,813 

manufacturing supplements; 987 

labeling supplements; and 147 efficacy 

supplements. CBER received 810 annual 

responses that include the following 

submissions: 9 biologics license 

applications; 743 manufacturing 

supplements; 48 labeling supplements; 

and 10 efficacy supplements. Based on 

the previous submissions that were 

received, the rate of these submissions 

is not expected to change significantly 

in the next few years. The estimated 

hours per response are based on past 

FDA experience with the various 

submissions, and the average is 30 

minutes. 

FDA is revising Form FDA 3397 in the 

following ways: (1) By including an 

additional question regarding 

redemption of a priority review 

voucher; (2) by deleting the exclusion 

for certain applications submitted under 

section 505(b)(2) of the FD&C Act (21 

U.S.C. 355(b)(2)); and (3) by making 

several minor editorial changes. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1

Form No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

FDA 3397 255 15.36 3,917 0.5 1,959 

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

Dated: June 1, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–13276 Filed 6–5–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–D–0369] (formerly 

Docket No. 2007D–0169) 

Draft and Revised Draft Guidances for 

Industry Describing Product-Specific 

Bioequivalence Recommendations; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of additional draft and 

revised draft product-specific 

bioequivalence (BE) recommendations. 

The recommendations provide productspecific guidance on the design of BE 

studies to support abbreviated new drug 

applications (ANDAs). In the Federal 

Register of May 31, 2007, FDA 

announced the availability of a draft 

guidance for industry entitled 

‘‘Bioequivalence Recommendations for 

Specific Products’’ explaining the 

process that would be used to make 

product-specific BE recommendations 

available to the public on FDA’s Web 

site. The BE recommendations 

identified in this notice were developed 

using the process described in that 

guidance. Elsewhere in this issue of the 

Federal Register, FDA is announcing 

the availability of final product-specific 

BE recommendations. 

DATES: Submit written or electronic 

comments on the draft and revised draft 

product-specific BE recommendations 

listed in this notice by September 8, 

2009. 

ADDRESSES: Submit written requests for 

single copies of the individual BE 

guidances to the Division of Drug 

Information, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, rm. 2201, Silver Spring, 

MD 20993–0002. Send one selfaddressed adhesive label to assist that 

office in processing your requests. 

Submit written comments on the draft 

product-specific BE recommendations 

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. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the 

recommendations. 

FOR FURTHER INFORMATION CONTACT: 

Doan T. Nguyen, Center for Drug 

Evaluation and Research (HFD–600), 

Food and Drug Administration, 7519 

Standish Pl., Rockville, MD 20855, 240– 

276–9314. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of May 31, 

2007 (72 FR 30388), FDA announced the 

availability of a draft guidance for 

industry entitled ‘‘Bioequivalence 

Recommendations for Specific 

Products’’ that explained the process 

that would be used to make productspecific BE recommendations available 

to the public on FDA’s Web site at 

http://www.fda.gov/cder/guidance/ 

bioequivalence/default.htm. As 

described in that draft guidance, FDA 

adopted this process as a means to 

develop and disseminate productspecific BE recommendations and 

provide a meaningful opportunity for 


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