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
53878 Federal Register / Vol. 73, No. 181 / Wednesday, September 17, 2008 / Notices 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section Form No. No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

720.1 through 720.4 (new 

submissions) 

FDA 25122 141 31 4371 0 .33 1,442 

720.4 and 720.6 (amendments) FDA 2512 109 7 763 0 .17 130 

720.3, 720.6 (notices of discontinuance) FDA 2512 55 41 2,255 0 .1 226 

720.8 (requests for confidentiality) 1 1 1 1 .5 1 .5 

Total 1,800 

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

2The term ‘‘Form FDA 2512’’ refers to both the paper Forms FDA 2512, 2512a, and 2514 and electronic Form FDA 2512 in the electronic system known as the Voluntary Cosmetic Registration Program, which is available at http://www.cfsan.fda.gov/~dms/cos-regn.html. 

The estimated number of respondents 

is based on submissions received from 

fiscal years 2005 to 2007. The estimated 

time required for each submission is 

based upon information from cosmetic 

industry personnel and FDA experience 

entering data submitted on paper Forms 

FDA 2512, 2512a, and 2514. The 

increase in total annual responses is due 

to increased participation by cosmetic 

companies, because of a renewed 

industry commitment to the program, 

and implementation of the online filing 

system on December 1, 2005. The 

decrease in hours per response is due to 

the ease of online filing. 

Please note that on January 15, 2008, 

the FDA Division of Dockets 

Management Web site transitioned to 

the Federal Dockets Management 

System (FDMS). FDMS is a 

Government-wide, electronic docket 

management system. Electronic 

comments or submissions will be 

accepted by FDA only through FDMS at 

http://www.regulations.gov. 

Dated: September 10, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–21617 Filed 9–16–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0487] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Food Safety 

Survey 

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 

reinstatement of an existing collection 

of information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

a voluntary consumer survey about food 

safety. 

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: 

I. Background 

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 reinstatement 

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. 

Food Safety Survey (OMB Control 

Number 0910–0345—Reinstatement) 

Under section 903(b)(2) of the Federal 

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

393(b)(2)), FDA is authorized to conduct 

research relating to foods and to 

conduct educational and public 

information programs relating to the 

safety of the nation’s food supply. The 

Food Safety Survey is a nationally 


pwalker on PROD1PC71 with NOTICES