Federal Register / Vol. 75, No. 103 / Friday, May 28, 2010 / Notices 30033 

Form Number of 

respondents 

Responses 

per 

respondents 

Total 

responses 

Hours per 

response 

Total burden 

hours 

Total .............................................................................. 463 ........................ 522,815 ........................ 278,765.95 

* Includes an estimated 2,500 kidney transplant patients transplanted prior to the initiation of the data system. 

E-mail comments to 

paperwork@hrsa.gov or mail the HRSA 

Reports Clearance Officer, Room 10–33, 

Parklawn Building, 5600 Fishers Lane, 

Rockville, MD 20857. Written comments 

should be received within 60 days of 

this notice. 

Dated: May 25, 2010. 

Sahira Rafiullah, 

Director, Division of Policy and Information 

Coordination. 

[FR Doc. 2010–12964 Filed 5–27–10; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0119] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Registration of 

Food Facilities 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 0910–0502. 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. 

Registration of Food Facilities Under 

the Public Health Security and 

Bioterrorism Preparedness and 

Response Act of 2002— (OMB Control 

Number 0910–0502)—Extension 

The Public Health Security and 

Bioterrorism Preparedness and 

Response Act of 2002 (the Bioterrorism 

Act) added section 415 of the Federal 

Food, Drug, and Cosmetic Act (the act) 

(21 U.S.C. 350d), which requires 

domestic and foreign facilities that 

manufacture, process, pack, or hold 

food for human or animal consumption 

in the United States to register with 

FDA. Sections 1.230 through 1.235 of 

FDA’s regulations (21 CFR 1.230 

through 1.235) set forth the procedures 

for registration of food facilities. 

Information provided to FDA under 

these regulations will help the agency to 

notify quickly the facilities that might 

be affected by a deliberate or accidental 

contamination of the food supply. 

Description of Respondents: The 

respondents to this information 

collection include owners, operators, or 

agents in charge of domestic or foreign 

facilities that manufacture/process, 

pack, or hold food for human or animal 

consumption in the United States. 

Domestic facilities are required to 

register whether or not food from the 

facility enters interstate commerce. 

Foreign facilities that manufacture/ 

process, pack, or hold food also are 

required to register unless food from 

that facility undergoes further 

processing (including packaging) by 

another foreign facility before the food 

is exported to the United States. 

However, if the subsequent foreign 

facility performs only a minimal 

activity, such as putting on a label, both 

facilities are required to register. 

FDA’s regulations require that each 

facility that manufactures, processes, 

packs, or holds food for human or 

animal consumption in the United 

States register with FDA using Form 

FDA 3537 (§ 1.231). The term ‘‘Form 

FDA 3537’’ refers to both the paper 

version of the form and the electronic 

system known as the Food Facility 

Registration Module, which is available 

at http://www.access.fda.gov. The 

agency strongly encourages electronic 

registration because it is faster and more 

convenient. The system the agency has 

developed can accept electronic 

registrations from anywhere in the 

world 24 hours a day, 7 days a week. A 

registering facility will receive 

confirmation of electronic registration 

and its registration number 

instantaneously once all the required 

fields on the registration screen are 

filled in. However, paper registrations 

will be accepted. Form FDA 3537 is 

available for download for registration 

by mail, fax, or CD–ROM. Registration 

by mail may take several weeks to 

several months, depending on the speed 

of the mail system and the number of 

paper registrations that FDA will have 

to enter manually. 

Information FDA requires on the 

registration form includes the name and 

full address of the facility; emergency 

contact information; all trade names the 

facility uses; applicable food product 

categories identified in § 170.3 (21 CFR 

170.3), unless ‘‘most/all’’ human food 

categories ‘‘or none of the above 

mandatory categories’’ is selected as a 

response; and a certification statement 

that includes the name of the individual 

authorized to submit the registration 

form. Additionally, facilities are 

encouraged to submit their preferred 

mailing address; type of activity 

conducted at the facility; food categories 

not included under § 170.3, but which 

are helpful to FDA for responding to an 

incident; type of storage, if the facility 

is primarily a holding facility; and 

approximate dates of operation if the 

facility’s business is seasonal. 

In addition to registering, a facility is 

required to submit timely updates 

within 60 days of a change to any 

required information on its registration 

form, using Form FDA 3537 (§ 1.234), 

and to cancel its registration when the 

facility ceases to operate or is sold to 

new owners or ceases to manufacture/ 

process, pack, or hold food for 

consumption in the United States, using 

Form FDA 3537a (§ 1.235). 

In the Federal Register of March 16, 

2010 (75 FR 12547), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 


jlentini on DSKJ8SOYB1PROD with NOTICES
30034 Federal Register / Vol. 75, No. 103 / Friday, May 28, 2010 / Notices 

information. FDA received one letter, 

containing multiple comments, in 

response to the notice. 

(Comment 1) One comment 

contended that it was unnecessary for 

companies to have to register their 

facilities with FDA. 

(Response) FDA disagrees. In the 

Preliminary Regulatory Impact Analysis 

(PRIA) for the proposed rule (see the 

Federal Register of Feburary 3, 2003 (68 

FR 5378 at 5387 to 5413)), FDA asserted 

that requiring registration of 

manufacturers/ processors, packers, and 

holders of food would aid in deterring 

and limiting the effects of foodborne 

outbreaks in four ways. One, by 

requiring registration, persons who 

might intentionally contaminate the 

food supply would be deterred from 

entering the food production chain. 

Two, if FDA is aware of a specific food 

threat, a registration database would 

make FDA better able to inform the 

facilities potentially affected by the 

threat. Three, FDA would be able to 

deploy more efficiently its domestic 

compliance and regulatory resources. 

Four, FDA inspectors, using prior notice 

and registration, would be better able to 

identify shipments offered for import for 

inspection. 

Registering with FDA creates a paper 

trail, which would, even if the 

information in the registration were 

falsified, provide evidence that could 

link the registration to the false 

registrant. Persons who might attempt to 

intentionally contaminate the U.S. food 

supply would be deterred, by the 

creation of additional evidence that 

might be used against them, from 

starting a business in the food supply 

chain. Persons who might intentionally 

contaminate the food supply but refuse 

to register would be subject to criminal 

and civil sanctions and, if foreign, 

would risk having their product held at 

a U.S. port. With emergency contact 

information and product categories, 

FDA can quickly call or e-mail the 

emergency contact at both domestic and 

foreign facilities that may be targeted by 

a specific food threat. If FDA suspects 

a particular product is at risk, the 

agency can quickly identify which 

facilities to contact. This rapid 

communication ability will allow 

facilities to respond quickly to a threat 

and possibly limit the effect of a 

deliberate strike on the food supply, as 

well as public health emergencies due 

to accidental contamination of food. 

(Comment 2) One comment stated 

that facilities that hold food should not 

be required to register. 

(Response) FDA disagrees with the 

suggested change to its regulations. The 

agency’s regulations implement the food 

facility registration requirements in 

section 305 of the Bioterrorism Act, 

which requires domestic and foreign 

facilities that manufacture, process, 

pack, or hold food for human or animal 

consumption in the United States to 

register with FDA. 

(Comment 3) One comment stated 

that, to lessen the burden of the 

regulation, FDA should not require 

firms to update their registration 

information, but only to cancel their 

registration when the facility stops 

holding food. 

(Response) FDA disagrees with the 

suggested change to its regulations. 

Requiring registrants to update the 

registration information for their 

facilities will directly enhance FDA’s 

ability to satisfy the agency’s obligation 

to maintain an up-to-date list of 

registered facilities, as required by 

section 415(a)(4) of the act. FDA has 

balanced the greater efficiency of the 

agency’s having specific information 

regarding food manufactured/processed, 

packed, or held at each facility against 

the burden on facilities to submit 

initially and update this information as 

circumstances change. Without updated 

emergency contact information and 

product categories, the agency’s ability 

to quickly call or e-mail the emergency 

contact at facilities that may be targeted 

by a specific food threat would be 

negatively impacted. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR 

Section FDA Form No. No. of Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours 

per Response Total Hours 

New Facilities 

Domestic 

1.230–1.233 FDA 35372 13,560 1 13,560 2.5 33,900 

Foreign 

1.230–1.233 FDA 3537 23,370 1 23,370 8.5 198,645 

New Facility Registration Subtotal 232,545 

Previously Registered Facilities-Updates (Form 3537) and Cancellations (Form 3537a) 

1.234 FDA 3537 118,530 1 118,530 1 118,530 

1.235 FDA 3537a 6,390 1 6,390 1 6,390 

Updates or Cancellations to Existing Registration Subtotal 124,920 

Total Hours Annually 357,465 

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

2The term ‘‘Form FDA 3537’’ refers to both the paper version of the form and the electronic system known as the Food Facility Registration 

Module, which is available at http://www.access.fda.gov. 

This estimate is based on FDA’s 

experience and the average number of 

new facility registrations, updates and 

cancellations received in the past 3 

years. FDA received 12,681 new 

domestic facility registrations during 

2006; 14,629 during 2007; and 13,378 

during 2008. Based on this experience, 

FDA estimates the annual number of 

new domestic facility registrations will 

be 13,560. FDA estimates that listing the 

information required by the 


jlentini on DSKJ8SOYB1PROD with NOTICES
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