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
Federal Register / Vol. 75, No. 103 / Friday, May 28, 2010 / Notices 30037 

Customs and Border Protection (CBP), to 

target import inspections more 

effectively and help protect the nation’s 

food supply against terrorist acts and 

other public health emergencies. 

Any person with knowledge of the 

required information may submit prior 

notice for an article of food. Thus, the 

respondents to this information 

collection may include importers, 

owners, ultimate consignees, shippers, 

and carriers. 

FDA’s regulations require that prior 

notice of imported food be submitted 

electronically using CBP’s Automated 

Broker Interface of the Automated 

Commercial System (ABI/ACS) 

(§ 1.280(a)(1)) or the FDA Prior Notice 

(PN) System Interface (Form FDA 3540) 

(§ 1.280(a)(2)). The term ‘‘Form FDA 

3540’’ refers to the electronic system 

known as the FDA PN System Interface, 

which is available at http:// 

www.access.fda.gov. Prior notice must 

be submitted electronically using either 

ABI/ACS or the FDA PN System 

Interface. Information collected by FDA 

in the prior notice submission includes: 

The submitter and transmitter (if 

different from the submitter); entry type 

and CBP identifier; the article of food, 

including complete FDA product code; 

the manufacturer, for an article of food 

no longer in its natural state; the grower, 

if known, for an article of food that is 

in its natural state; the FDA Country of 

Production; the shipper, except for food 

imported by international mail; the 

country from which the article of food 

is shipped or, if the food is imported by 

international mail, the anticipated date 

of mailing and country from which the 

food is mailed; the anticipated arrival 

information or, if the food is imported 

by international mail, the U.S. recipient; 

the importer, owner, and ultimate 

consignee, except for food imported by 

international mail or transshipped 

through the United States; the carrier 

and mode of transportation, except for 

food imported by international mail; 

and planned shipment information, 

except for food imported by 

international mail (§ 1.281). 

Much of the information collected for 

prior notice is identical to the 

information collected for FDA’s 

importer’s entry notice, which has been 

approved under OMB control number 

0910–0046. The information in FDA’s 

importer’s entry notice is collected 

electronically via CBP’s ABI/ACS at the 

same time the respondent files an entry 

for import with CBP. To avoid doublecounting the burden hours are already 

accounted for in the importer’s entry 

notice information collection, and the 

burden hour analysis in table 1 of this 

document reflects the reduced burden 

for prior notice submitted through ABI/ 

ACS in the column labeled ‘‘Hours per 

Response.’’ 

In addition to submitting a prior 

notice, a submitter should cancel a prior 

notice and must resubmit the 

information if information changes after 

FDA has confirmed a prior notice 

submission for review (e.g., if the 

identity of the manufacturer changes) 

(§ 1.282). However, changes in the 

estimated quantity, anticipated arrival 

information, or planned shipment 

information do not require resubmission 

of prior notice after FDA has confirmed 

a prior notice submission for review 

(§ 1.282(a)(1)(i) through (a)(1)(iii)). In 

the event that an article of food has been 

refused admission under section 

801(m)(1) or placed under hold under 

section 801(l) of the act, §§ 1.283(d) and 

1.285(j) set forth the procedure for 

requesting FDA review and the 

information required to be included in 

a request for review. In the event that an 

article of food has been placed under 

hold under section 801(l) of the act, 

§ 1.285(i) sets forth the procedure for 

and the information to be included in a 

post-hold submission. 

In accordance with 5 CFR 1320.8(d), 

in the Federal Register of March 16, 

2010 (75 FR 12549), 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 this notice. These comments 

were outside the scope of the four 

collection of information topics on 

which the notice solicits public 

comment and, thus, will not be 

addressed here. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR 

Section No. 

FDA 

Form No. 

No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

Prior Notice Submissions 

Prior Notice submitted through ABI/ACS 

1.280 through 1.281 None 6,500 1,290 8,385,000 0 .15 1,257,7502

Prior Notice submitted through PN System Interface 

1.280 through 1.281 FDA 35403 21,500 73 1,569,500 0 .37 580,715 

New Prior Notice Submissions Subtotal 1,838,465 

Prior Notice Cancellations 

Prior Notice cancelled through ABI/ACS 

1.282 FDA 3540 6,500 3 19,500 0 .25 4,875 

Prior Notice cancelled through PN System Interface 

1.282 and 1.283(a)(5) FDA 3540 21,500 3 64,500 0 .25 16,125 

Prior Notice Cancellations Subtotal 21,000 

Prior Notice Requests for Review and Post-hold Submissions 

1.283(d) and 1.285(j) None 1 1 1 8 8 


jlentini on DSKJ8SOYB1PROD with NOTICES
30038 Federal Register / Vol. 75, No. 103 / Friday, May 28, 2010 / Notices 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued 

21 CFR 

Section No. 

FDA 

Form No. 

No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

1.285(i) None 1 1 1 1 1 

Prior Notice Requests for Review and Post-hold Submissions Subtotal 9 

Total Hours Annually 1,859,474 

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

2To avoid double-counting, an estimated 396,416 burden hours already accounted for in the Importer’s Entry Notice information collection approved under OMB control number 0910–0046 are not included in this total. 3The term ‘‘Form FDA 3540’’ refers to the electronic system known as the FDA PN System Interface, which is available at http:// 

www.access.fda.gov. 

This estimate is based on FDA’s 

experience and the average number of 

prior notice submissions, cancellations, 

and requests for review received in the 

past 3 years. 

On November 7, 2008, FDA and CBP 

issued the prior notice final rule (73 FR 

66294), which finalized the prior notice 

interim final rule (IFR) (68 FR 58894, 

October 10, 2003). From the IFR to the 

final rule, FDA removed a few of the 

required prior notice data elements. 

Specifically, submitters no longer need 

to include the fax number of the 

submitter and transmitter, the 

anticipated border crossing, the country 

of the carrier, or the 6-digit HTS code 

in their prior notices. Other changes 

include the addition of the registration 

number of the transshipper for articles 

of food for transshipment, storage and 

export, or manipulation and export; 

flexibility in submitting the registration 

number and the city and country of the 

manufacturer and shipper instead of full 

addresses of these entities; and the 

option of submitting the tracking 

number for articles of food arriving by 

express consignment instead of 

anticipated arrival information when 

the prior notice is submitted through PN 

System Interface (73 FR 66294 at 

66402). 

Accordingly, FDA has reduced its 

estimate of the hours per response for 

prior notices received through ABI/ACS 

from 10 minutes, or 0.167 hours, per 

notice, to 9 minutes, or 0.15 hours, per 

notice. FDA received 8,144,419 prior 

notices through ABI/ACS during 2007; 

8,266,200 during 2008; and 5,221,549 as 

of August 26, 2009. Based on this 

experience, FDA estimates that 

approximately 6,500 users of ABI/ACS 

will submit an average of 1,290 prior 

notices annually, for a total of 8,385,000 

prior notices received annually through 

ABI/ACS. FDA estimates the reporting 

burden for a prior notice submitted 

through ABI/ACS to be 9 minutes, or 

0.15 hours, per notice, for a total burden 

of 1,257,750 hours. This estimate takes 

into consideration the burden hours 

already counted in the information 

collection approval for FDA’s importer’s 

entry notice, as previously discussed in 

this document. 

FDA has also reduced its estimate of 

the hours per response for prior notices 

received through the PN System 

Interface from 23 minutes to 22 minutes. 

FDA received 1,744,287 prior notices 

through the PN System Interface during 

2007; 1,662,033 during 2008; and 

989,708 as of August 26, 2009. Based on 

this experience, FDA estimates that 

approximately 21,500 registered users of 

the PN System Interface will submit an 

average of 73 prior notices annually, for 

a total of 1,569,500 prior notices 

received annually through the PN 

System Interface. FDA estimates the 

reporting burden for a prior notice 

submitted through the PN System 

Interface to be 22 minutes, or 0.366 

hours (rounded to 0.37 hours), per 

notice, for a total burden of 580,715 

hours. 

FDA received 16,215 cancellations of 

prior notices through ABI/ACS during 

2007; 16,673 during 2008; and 16,045 as 

of August 26, 2009. Based on this 

experience, FDA estimates that 

approximately 6,500 users of ABI/ACS 

will submit an average of 2.64 (rounded 

to 3) cancellations annually, for a total 

of 19,500 cancellations received 

annually through ABI/ACS. FDA 

estimates the reporting burden for a 

cancellation submitted through ABI/ 

ACS to be 15 minutes, or 0.25 hours, per 

cancellation, for a total burden of 4,875 

hours. 

FDA received 58,345 cancellations of 

prior notices through the PN System 

Interface during 2007; 63,779 during 

2008; and 55,019 as of August 26, 2009. 

Based on this experience, FDA estimates 

that approximately 21,500 registered 

users of the PN System Interface will 

submit an average of 3.24 (rounded to 3) 

cancellations annually, for a total of 

64,500 cancellations received annually 

through the PN System Interface. FDA 

estimates the reporting burden for a 

cancellation submitted through the PN 

System Interface to be 15 minutes, or 

0.25 hours, per cancellation, for a total 

burden of 16,125 hours. 

FDA has not received any requests for 

review under §§ 1.283(d) or 1.285(j) in 

the last 3 years (2007 through August 

26, 2009); therefore, the agency 

estimates that one or fewer requests for 

review will be submitted annually. FDA 

estimates that it will take a requestor 

about 8 hours to prepare the factual and 

legal information necessary to prepare a 

request for review. Thus, FDA has 

estimated a total reporting burden of 8 

hours. 

FDA has not received any post-hold 

submissions under § 1.285(i) in the last 

3 years (2007 through August 26, 2009); 

therefore, the agency estimates that one 

or fewer post-hold submissions will be 

submitted annually. FDA estimates that 

it will take about 1 hour to prepare the 

written notification described in 

§ 1.285(i)(2)(i). Thus, FDA has estimated 

a total reporting burden of 1 hour. 

Dated: May 24, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–12866 Filed 5–27–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Office of Administration; Matching 

Requirements on Grants Awarded 

Under Children’s Bureau Funding 

Opportunity Announcement for Fiscal 

Year 2010 

AGENCY: Division of Grants Policy, 

Office of Financial Services, Office of 

Administration, Administration for 

Children and Families (ACF), 

Department of Health and Human 

Services (HHS). 

ACTION: Notice. 

CFDA Number: 93.648. 


jlentini on DSKJ8SOYB1PROD with NOTICES