Federal Register / Vol. 76, No. 38 / Friday, February 25, 2011 / Notices 10607 

Dated: February 18, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–4219 Filed 2–24–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0623] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Voluntary 

Cosmetic Registration Program 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by March 28, 

2011. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0027. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley, Jr., Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

3793. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Voluntary Cosmetic Registration 

Program—21 CFR Parts 710 and 720 

(OMB Control Number 0910–0027)— 

Revision 

The Federal Food, Drug, and Cosmetic 

Act (the FD&C Act) provides FDA with 

the authority to regulate cosmetic 

products in the United States. Cosmetic 

products that are adulterated under 

section 601 of the FD&C Act (21 U.S.C. 

361) or misbranded under section 602 of 

the FD&C 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 21 CFR part 710, FDA requests that 

establishments that manufacture or 

package cosmetic products register with 

the Agency on Form FDA 2511 entitled 

‘‘Registration of Cosmetic Product 

Establishment.’’ The term ‘‘Form FDA 

2511’’ refers to both the paper and 

electronic versions of the form. The 

electronic version of Form FDA 2511 is 

available on FDA’s VCRP Web site at 

http://www.fda.gov/Cosmetics/

GuidanceComplianceRegulatory

Information/

VoluntaryCosmeticsRegistration

ProgramVCRP/OnlineRegistration/

default.htm. FDA’s online registration 

system, intended to make it easier to 

participate in the VCRP, was made 

available industrywide on December 1, 

2005. The Agency strongly encourages 

electronic registration of Form FDA 

2511 because it is faster and more 

convenient. A registering facility will 

receive confirmation of electronic 

registration, including a registration 

number, by e-mail, usually within 7 

business days. The online system also 

allows for amendments to past 

submissions. 

Because registration of cosmetic 

product establishments is not 

mandatory, voluntary registration 

provides FDA with the best information 

available about the locations, business 

trade names, and types of activity 

(manufacturing or packaging) of 

cosmetic product establishments. FDA 

places the registration information in a 

computer database and uses the 

information to generate mailing lists for 

distributing regulatory information and 

for inviting firms to participate in 

workshops on topics in which they may 

be interested. FDA also uses the 

information for estimating the size of 

the cosmetic industry and for 

conducting onsite establishment 

inspections. Registration is permanent, 

although FDA requests that respondents 

submit an amended Form FDA 2511 if 

any of the originally submitted 

information changes. 

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 

(§ 720.6) 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, 

‘‘Notice of 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 is available 

on FDA’s VCRP Web site at http:// 

www.fda.gov/Cosmetics/

GuidanceComplianceRegulatory

Information/

VoluntaryCosmeticsRegistration

ProgramVCRP/OnlineRegistration/ 

default.htm. 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 filer will receive confirmation of 

electronic filing by e-mail. 

FDA places cosmetic product filing 

information in a computer database 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. 

In the Federal Register of December 

15, 2010 (75 FR 78257), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. FDA received one letter, 

containing multiple comments in 

response to the notice. 

(Comment 1) One comment was 

generally supportive of the necessity of 

the information collection and its 

practical utility. 


srobinson on DSKHWCL6B1PROD with NOTICES
10608 Federal Register / Vol. 76, No. 38 / Friday, February 25, 2011 / Notices 

(Response) FDA agrees that the VCRP 

provides the Agency with useful 

information about cosmetic product 

ingredients and the cosmetics industry. 

(Comment 2) One comment stated 

that, to increase participation in the 

registration program, FDA should 

conduct an audit of the cosmetics 

industry to determine the current 

participation rate in the registration 

program and to estimate how many 

ingredients and products FDA receives 

into the database compared to the total 

produced. 

(Response) FDA disagrees with the 

suggested audit of the cosmetics 

industry. Given that FDA does not have 

the statutory authority to make 

registration in the VCRP mandatory, and 

taking into consideration the cost of 

completing such a project, the audit 

would not be a wise use of Agency 

funds in the current economic 

environment. 

(Comment 4) As another means of 

increasing participation in the 

registration program, one comment 

suggested that FDA launch a 

certification system where companies 

can indicate to consumers that they 

have participated in the VCRP. 

(Response) FDA disagrees with the 

suggested certification program at this 

time. Before instituting such a program, 

FDA would need to conduct research to 

understand how consumers would 

interpret such a certification claim and 

would have to consider how the 

accuracy of such a claim would be 

enforced. 

(Comment 5) One comment stated 

that FDA should permit companies that 

produce professional-use products to 

submit contact and ingredient 

information. 

(Response) FDA disagrees with the 

suggested change to its registration 

program. Cosmetic products marketed 

in the United States are regulated by 

FDA in accordance with the 

requirements of the FD&C Act and, if 

offered for sale as consumer 

commodities, the Fair Packaging and 

Labeling Act (FPLA). The FPLA defines 

a consumer commodity as a product 

distributed through retail sales for 

consumption by individuals. 

Professional products used in salons, 

and free samples are not available 

through retail sale to consumers, so they 

are not considered to be in ‘‘commercial 

distribution’’. Because the VCRP 

program only applies to cosmetic 

products in commercial distribution as 

defined in the FPLA, FDA is unable to 

file professional cosmetic products. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section or part Form no. No. of 

respondents 

Annual frequency 

per response 

Total annual 

responses 

Hours 

per response Total hours 

Part 710 (registrations) ..... FDA 251 12 ..... 135 1 135 0 .2 27 

720.1 through 720.4 (new 

submissions).

FDA 2512 3 ..... 141 31 4,371 0 .33 1,442 

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

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

720.8 (requests for confidentiality).......................... 1 1 1 2 .0 2.0 

Total ........................... ......................... ............................ ............................ ............................ .............................. 1,827 

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

2The term ‘‘Form FDA 2511’’ refers to both the paper Forms FDA 2511 and electronic Form FDA 2511 in the electronic system known as the 

VCRP, which is available at http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/VoluntaryCosmeticsRegistrationProgram

VCRP/OnlineRegistration/default.htm. 3The term ‘‘Form FDA 2512’’ refers to the paper Forms FDA 2512, 2512a, and 2514 and electronic Form FDA 2512 in the electronic system 

known as the VCRP, which is available at http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/VoluntaryCosmeticsRegistrationProgramVCRP/OnlineRegistration/default.htm. 

FDA bases its estimate of the number 

of responses on submissions received 

from fiscal years 2005 to 2007. FDA 

bases its estimate of the hours per 

response upon information from 

cosmetic industry personnel and FDA 

experience entering data submitted on 

paper Forms 2511, 2512, 2512a, and 

2514. FDA estimates that, annually, 135 

establishments that manufacture or 

package cosmetic products will each 

submit 1 registration on Form FDA 

2511, for a total of 135 annual 

responses. Each submission is estimated 

to take 0.2 hour per response for a total 

of 27 hours. FDA estimates that, 

annually, 141 firms that manufacture, 

pack, or distribute cosmetics will file 31 

ingredient statements for new 

submissions on Forms FDA 2512 and 

FDA 2512a, for a total of 4,371 annual 

responses. Each submission is estimated 

to take 0.33 hour per response for a total 

of 1,442.43 hours, rounded to 1,442. 

FDA estimates that, annually, 109 firms 

that manufacture, pack, or distribute 

cosmetics will file 7 amendments to 

product formulations on Forms FDA 

2512 and FDA 2512a, for a total of 763 

annual responses. Each submission is 

estimated to take 0.17 hour per response 

for a total of 129.71 hours, rounded to 

130. FDA estimates that, annually, 55 

firms that manufacture, pack, or 

distribute cosmetics will file 41 notices 

of discontinuance on Form FDA 2514, 

for a total of 2,255 annual responses. 

Each submission is estimated to take 0.1 

hour per response for a total of 225.50 

hours, rounded to 226. FDA estimates 

that, annually, one firm will file one 

request for confidentiality. Each such 

request is estimated to take 2 hours to 

prepare for a total of 2.0 hours. Thus, 

the total estimated hour burden for this 

information collection is 1,827 hours. 

This is a revision request in which the 

burden hours for the information 

collection request (ICR) under OMB 

control number 0910–0030, ‘‘Cosmetic 

Product Voluntary Reporting Program’’ 

are being consolidated under the ICR 

assigned OMB control number 0910– 

0027, ‘‘Voluntary Registration of 

Cosmetic Product Establishments,’’ 

which expires February 28, 2011. The 

revised ICR for 0910–0027 has been 

renamed ‘‘Voluntary Cosmetic 

Registration Program.’’ Upon approval of 

this revision request, the ICR for OMB 

control number 0910–0030 will be 

discontinued. 

Dated: February 18, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–4218 Filed 2–24–11; 8:45 am] 

BILLING CODE 4160–01–P 


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