Federal Register / Vol. 75, No. 103 / Friday, May 28, 2010 / Notices 30035 

Bioterrorism Act and presenting it in a 

format that will meet the agency’s 

registration regulations will require a 

burden of approximately 2.5 hours per 

average domestic facility registration. 

The average domestic facility burden 

hour estimate of 2.5 hours takes into 

account that some respondents 

completing the registration may not 

have readily available Internet access. 

Thus, the total annual burden for new 

domestic facility registrations is 

estimated to be 33,900 hours (13,560 x 

2.5 hours). 

FDA received 25,513 new foreign 

facility registrations during 2006; 23,302 

during 2007; and 21,281 during 2008. 

Based on this experience, FDA estimates 

the annual number of new foreign 

facility registrations will be 23,370. FDA 

estimates that listing the information 

required by the Bioterrorism Act and 

presenting it in a format that will meet 

the agency’s registration regulations will 

require a burden of approximately 8.5 

hours per average foreign facility 

registration. The average foreign facility 

burden hour estimate of 8.5 hours 

includes an estimate of the additional 

burden on a foreign facility to obtain a 

U.S. agent, and takes into account that 

for some foreign facilities the 

respondent completing the registration 

may not be fluent in English and/or not 

have readily available Internet access. 

Thus, the total annual burden for new 

foreign facility registrations is estimated 

to be 198,645 hours (23,370 x 8.5 hours). 

FDA received 114,199 updates to 

facility registrations during 2006; 

128,070 during 2007; and 113,318 

during 2008. Based on this experience, 

FDA estimates that it will receive 

118,530 updates annually. FDA also 

estimates that updating a registration 

will, on average, require a burden of 

approximately 1 hour, taking into 

account fluency in English and Internet 

access. Thus, the total annual burden for 

updating all registrations is estimated to 

be 118,530 hours. 

FDA received 5,703 cancellations of 

facility registrations during 2006; 5,578 

during 2007; and 7,888 during 2008. 

Based on this experience, FDA estimates 

the annual number of cancellations will 

be 6,390. FDA also estimates that 

cancelling a registration will, on 

average, require a burden of 

approximately 1 hour, taking into 

account fluency in English and Internet 

access. Thus, the total annual burden for 

cancelling registrations is estimated to 

be 6,390 hours. 

Dated: May 25, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–13003 Filed 5–27–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0120] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Cosmetic Labeling 

Regulations 

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 

(the PRA). 

DATES: Fax written comments on the 

collection of information by June 28, 

2010.. 

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 0910–0599. 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. 

Cosmetic Labeling Regulations—(OMB 

Control Number 0910–0599)—Extension 

The Federal Food, Drug, and Cosmetic 

Act (the act) and the Fair Packaging and 

Labeling Act (the FPLA) require that 

cosmetic manufacturers, packers, and 

distributors disclose information about 

themselves or their products on the 

labels or labeling of their products. 

Sections 201, 502, 601, 602, 603, 701, 

and 704 of the act (21 U.S.C. 321, 352, 

361, 362, 363, 371, and 374) and 

sections 4 and 5 of the FPLA (15 U.S.C. 

1453 and 1454) provide authority to 

FDA to regulate the labeling of cosmetic 

products. Failure to comply with the 

requirements for cosmetic labeling may 

render a cosmetic adulterated under 

section 601 of the act or misbranded 

under section 602 of the act. 

FDA’s cosmetic labeling regulations 

are published in part 701 (21 CFR part 

701). Four of the cosmetic labeling 

regulations have information collection 

provisions. Section 701.3 requires the 

label of a cosmetic product to bear a 

declaration of the ingredients in 

descending order of predominance. 

Section 701.11 requires the principal 

display panel of a cosmetic product to 

bear a statement of the identity of the 

product. Section 701.12 requires the 

label of a cosmetic product to specify 

the name and place of business of the 

manufacturer, packer, or distributor. 

Section 701.13 requires the label of a 

cosmetic product to declare the net 

quantity of contents of the product. 

FDA’s cosmetic labeling regulations 

remain unchanged by this notice. FDA 

is publishing this notice in compliance 

with the PRA. This notice does not 

represent any new regulatory initiative. 

In the Federal Register of March 16, 

2010 (75 FR 12546), 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. One comment 

expressed strong support for the 

labeling of cosmetics. Additional 

comments were outside the scope of the 

four collection of information topics on 

which the notice solicits comments and, 

thus, will not be addressed here. 

FDA estimates the annual burden of 

this collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL THIRD PARTY DISCLOSURE BURDEN1

21 CFR Section No. of 

Respondents 

Annual Frequency 

of Disclosure 

Total Annual 

Disclosures 

Hours per 

Disclosure Total Hours 

701.3 1,518 21 31,878 1 31,878 


jlentini on DSKJ8SOYB1PROD with NOTICES
30036 Federal Register / Vol. 75, No. 103 / Friday, May 28, 2010 / Notices 

TABLE 1.—ESTIMATED ANNUAL THIRD PARTY DISCLOSURE BURDEN1—Continued 

21 CFR Section No. of 

Respondents 

Annual Frequency 

of Disclosure 

Total Annual 

Disclosures 

Hours per 

Disclosure Total Hours 

701.11 1,518 24 36,432 1 36,432 

701.12 1,518 24 36,432 1 36,432 

701.13 1,518 24 36,432 1 36,432 

Total 141,174 

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

The hour burden is the additional or 

incremental time that establishments 

need to design and print labeling that 

includes the following required 

elements: A declaration of ingredients 

in decreasing order of predominance, a 

statement of the identity of the product, 

a specification of the name and place of 

business of the establishment, and a 

declaration of the net quantity of 

contents. These requirements increase 

the time establishments need to design 

labels because they increase the number 

of label elements that establishments 

must take into account when designing 

labels. These requirements do not 

generate any recurring burden per label 

because establishments must already 

print and affix labels to cosmetic 

products as part of normal business 

practices. 

According to the 2001 census, there 

are 1,518 cosmetic product 

establishments in the United States 

(U.S. Census Bureau, http:// 

www.census.gov/epcd/susb/2001/us/ 

US32562.HTM). FDA calculates label 

design costs based on stockkeeping 

units (SKUs) because each SKU has a 

unique product label. Based on data 

available to the Agency and on 

communications with industry, FDA 

estimates that cosmetic establishments 

will offer 94,800 SKUs for retail sale in 

2010. This corresponds to an average of 

62 SKUs per establishment. 

One of the four provisions that FDA 

discusses in this information collection, 

§ 701.3, applies only to cosmetic 

products offered for retail sale. 

However, the other three provisions, 

§§ 701.11, 701.12, and 701.13, apply to 

all cosmetic products, including nonretail professional-use-only products. 

FDA estimates that including 

professional-use-only cosmetic products 

increases the total number of SKUs by 

15 percent to 109,020. This corresponds 

to an average of 72 SKUs per 

establishment. 

Finally, based on the Agency’s 

experience with other products, FDA 

estimates that cosmetic establishments 

may redesign up to one-third of SKUs 

per year. Therefore, FDA estimates that 

the annual frequency of response will be 

21 (31,878 SKUs) for § 701.3 and 24 

each (36,432 SKUs) for §§ 701.11, 

701.12, and 701.13. 

FDA estimates that each of the 

required label elements may add 

approximately 1 hour to the label design 

process. FDA bases this estimate on the 

hour burdens the Agency has previously 

estimated for food, drug, and medical 

device labeling and on the Agency’s 

knowledge of cosmetic labeling. 

Therefore, FDA estimates that the total 

hour burden on members of the public 

for this information collection is 

141,174 hours per year. 

Dated: May 25, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–13075 Filed 5–27–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0118] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Prior Notice of 

Imported Food Under the Public Health 

Security and Bioterrorism 

Preparedness and Response Act of 

2002 

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 June 28, 

2010. 

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 0910–0520. 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. 

Prior Notice of Imported Food Under 

the Public Health Security and 

Bioterrorism Preparedness and 

Response Act of 2002—(OMB Control 

Number 0910–0520)—Extension 

The Public Health Security and 

Bioterrorism Preparedness and 

Response Act of 2002 (the Bioterrorism 

Act) added section 801(m) of the 

Federal Food, Drug, and Cosmetic Act 

(the act) (21 U.S.C. 381(m)), which 

requires that FDA receive prior notice 

for food, including food for animals, 

that is imported or offered for import 

into the United States. Sections 1.278 

through 1.282 of FDA’s regulations (21 

CFR 1.278 through 1.282) set forth the 

requirements for submitting prior 

notice; §§ 1.283(d) and 1.285(j) (21 CFR 

1.283(d) and 1.285(j)) set forth the 

procedure for requesting FDA review 

after an article of food has been refused 

admission under section 801(m)(1) of 

the act or placed under hold under 

section 801(l) of the act; and § 1.285(i) 

(21 CFR 1.285(i)) sets forth the 

procedure for post-hold submissions. 

Advance notice of imported food allows 

FDA, with the support of the U.S. 


jlentini on DSKJ8SOYB1PROD with NOTICES