53876 Federal Register / Vol. 73, No. 181 / Wednesday, September 17, 2008 / Notices 

For Further Information Contact: 

Sandra M. Peay, Contact Representative, 

or Renee Hallman, Contact 

Representative, Federal Trade 

Commission, Premerger Notification 

Office, Bureau Of Competition, Room 

H–303, Washington, DC 20580, (202) 

326–3100. 

By Direction of the Commission. 

Donald S. Clark, 

Secretary. 

[FR Doc. E8–21466 Filed 9–16–08; 8:45 am] 

BILLING CODE 6750–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60-Day–08–08BP] 

Proposed Data Collections Submitted 

for Public Comment and 

Recommendations 

In compliance with the requirement 

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

Paperwork Reduction Act of 1995 for 

opportunity for public comment on 

proposed data collection projects, the 

Centers for Disease Control and 

Prevention (CDC) will publish periodic 

summaries of proposed projects. To 

request more information on the 

proposed projects or to obtain a copy of 

the data collection plans and 

instruments, call 404–639–5960 and 

send comments to Maryam Daneshvar, 

CDC Acting Reports Clearance Officer, 

1600 Clifton Road, MS–D74, Atlanta, 

GA 30333 or send an e-mail to 

omb@cdc.gov. 

Comments are invited 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) 

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 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. Written comments should 

be received within 60 days of this 

notice. 

Proposed Project 

Audience Profiling for Carbon 

Monoxide Poisoning Prevention 

Status—New—National Center for 

Environmental Health (NCEH), 

Coordinating Center for Environmental 

Health and Injury Prevention (CCEHIP), 

Centers for Disease Control and 

Prevention (CDC). 

Background and Brief Description 

Carbon monoxide (CO) is one of the 

leading causes of poison-related deaths 

in the United States. The Centers for 

Disease Control and Prevention (CDC) 

estimates that each year approximately 

500 people die of unintentional, 

nonfire-related CO exposure, and 

another 15,000 individuals visit 

emergency rooms for treatment from 

exposure to CO gas. 

Despite our current knowledge of 

scenarios and products that lead to CO 

poisoning, questions remain about when 

and how individuals use CO-emitting 

products, why they engage in certain 

risk behaviors, how best to inform them 

about the CO poisoning, and how 

receptive they are to existing prevention 

materials. This study aims to address 

these questions through assessing the 

basis for current audience knowledge, 

attitudes, and practices and, ultimately, 

strengthen educational materials about 

CO poisoning prevention. 

The study will employ the use of 

qualitative methods during three phases 

of data collection. Phase I will consist 

of eight in-person focus groups among 

home furnace owners and portable 

generator owners (n=64) as well as four 

telephone interviews with organizations 

that serve populations at risk for CO 

poisoning (n=4). Phase II will consist of 

analyzing previously collected data on 

consumer media usage and preferences. 

Phase III will consist of 16 in-person 

triad interviews (3 individuals per 

interview) with home furnace owners 

and portable generator owners (n=48) to 

pretest CO poisoning educational 

materials. 

NCEH will identify individuals for the 

focus groups and triad interviews using 

recruiting firms that specialize in the 

two at-risk populations: 1. home furnace 

owners and 2. portable generator 

owners. Individuals in these two groups 

will be screened over the telephone by 

the recruiting firms, and if they meet the 

eligibility criteria, will be invited to 

participate in the study. At the end of 

each focus group and triad interview, 

NCEH will ask participants to complete 

a brief exit questionnaire on 

demographics and media usage. 

There is no cost to respondents other 

than their time. 

ESTIMATED ANNUALIZED BURDEN HOURS

Respondents (focus group, 

phone interview, and triad participants) Instrument type Number of 

respondents 

Number of 

responses per 

respondent 

Average burden 

per response 

(in hours) 

Total burden 

(in hours) 

Owners of Gas or Oil Burning 

Household Appliances.

Focus Group Screener .............

Focus Group .............................

Exit Questionnaire ....................

Triad Screener ..........................

Triad ..........................................

64 

32 

32 

48 

24 

1 

1 

1 

1 

1 

10/60 

2 

10/60 

10/60 

2 

11 

64 

5 

8 

48 

Owners of Portable Gas Burning Generator.Focus Group Screener .............

Focus Group .............................

Exit Questionnaire ....................

Triad Screener ..........................

Triad ..........................................

64 

32 

32 

48 

24 

1 

1 

1 

1 

1 

10/60 

2 

10/60 

10/60 

2 

11 

64 

5 

8 

48 

Expert ....................................... Telephone Interview ................. 4 1 1 4 

Total ................................... ................................................... ............................ ............................ ............................ 276 


pwalker on PROD1PC71 with NOTICES
Federal Register / Vol. 73, No. 181 / Wednesday, September 17, 2008 / Notices 53877 

Dated: September 11, 2008. 

Maryam Daneshvar, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. E8–21690 Filed 9–16–08; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0490] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Voluntary 

Cosmetic Registration Program 

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 

the collection of information associated 

with the Voluntary Cosmetic 

Registration Program. 

DATES: Submit written or electronic 

comments on the collection of 

information by November 17, 2008. 

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 

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. 

Voluntary Cosmetic Registration 

Program—21 CFR Part 720 (OMB 

Control Number 0910–0030)—Extension 

The Federal Food, Drug, and Cosmetic 

Act (the act) provides FDA with the 

authority to regulate cosmetic products 

in the United States. Cosmetic products 

that are adulterated under section 601 of 

the act (21 U.S.C. 361) or misbranded 

under section 602 of the act (21 U.S.C. 

362) may not be distributed in interstate 

commerce. To assist FDA in carrying 

out its responsibility to regulate 

cosmetics, the agency has developed the 

Voluntary Cosmetic Registration 

Program (VCRP). In part 720 (21 CFR 

part 720), FDA requests that firms that 

manufacture, pack, or distribute 

cosmetics file with the agency an 

ingredient statement for each of their 

products. Ingredient statements for new 

submissions (§§ 720.1 through 720.4) 

are reported on Form FDA 2512, 

‘‘Cosmetic Product Ingredient 

Statement,’’ and on Form FDA 2512a, a 

continuation form. Amendments to 

product formulations (§§ 720.3, 720.4, 

and 720.6) also are reported on Forms 

FDA 2512 and FDA 2512a. When a firm 

discontinues the commercial 

distribution of a cosmetic, FDA requests 

that the firm file Form FDA 2514, 

‘‘Discontinuance of Commercial 

Distribution of Cosmetic Product 

Formulation’’ (§§ 720.3 and 720.6). If 

any of the information submitted on or 

with these forms is confidential, the 

firm may submit a request for 

confidentiality under § 720.8. 

FDA’s online filing system, intended 

to make it easier to participate in the 

VCRP, was made available industrywide on December 1, 2005. The online 

filing system is available on FDA’s 

VCRP Web site at http:// 

www.cfsan.fda.gov/~dms/cosregn.html. The online filing system 

contains the electronic versions of 

Forms FDA 2512, 2512a, and 2514, 

which are collectively found within the 

electronic version of Form FDA 2512. 

The agency strongly encourages 

electronic filing of Form FDA 2512 

because it is faster and more convenient. 

A filing facility will receive 

confirmation of electronic filing by email. Submission of the paper version of 

Forms FDA 2512, 2512a, and 2514 

remains an option as described in 

http://www.cfsan.fda.gov/~dms/cosreg2.html. However, due to the high 

volume of online participation, the 

VCRP is allocating its limited resources 

primarily to electronic filings. 

FDA places cosmetic product filing 

information in a computer data base and 

uses the information for evaluation of 

cosmetic products currently on the 

market. Because filing of cosmetic 

product formulations is not mandatory, 

voluntary filings provide FDA with the 

best information available about 

cosmetic product ingredients and their 

frequency of use, businesses engaged in 

the manufacture and distribution of 

cosmetics, and approximate rates of 

product discontinuance and formula 

modifications. The information assists 

FDA scientists in evaluating reports of 

alleged injuries and adverse reactions 

from the use of cosmetics. The 

information also is used in defining and 

planning analytical and toxicological 

studies pertaining to cosmetics. 

Information from the database is 

releasable to the public under FDA 

compliance with the Freedom of 

Information Act. FDA shares 

nonconfidential information from its 

files on cosmetics with consumers, 

medical professionals, and industry. 

FDA estimates the burden of this 

collection of information as follows: 


pwalker on PROD1PC71 with NOTICES