30032 Federal Register / Vol. 75, No. 103 / Friday, May 28, 2010 / Notices 

comments and suggestions submitted 

within 60 days of this publication. 

Dated: May 25, 2010. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2010–12877 Filed 5–27–10; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: 

Comment Request 

In compliance with the requirement 

for opportunity for public comment on 

proposed data collection projects 

(section 3506(c)(2)(A) of Title 44, United 

States Code, as amended by the 

Paperwork Reduction Act of 1995, Pub. 

L. 104–13), the Health Resources and 

Services Administration (HRSA) 

publishes periodic summaries of 

proposed projects being developed for 

submission to the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995. To request more 

information on the proposed project or 

to obtain a copy of the data collection 

plans and draft instruments, e-mail 

paperwork@hrsa.gov or call the HRSA 

Reports Clearance Officer at (301) 443– 

1129. 

Comments are invited on: (a) The 

proposed collection of information for 

the proper performance of the functions 

of the agency; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. 

Proposed Project: Organ Procurement 

and Transplantation Network and 

Scientific Registry of Transplant 

Recipients Data System (OMB No. 

0915–0157)—Extension 

Section 372 of the Public Health 

Service (PHS) Act requires that the 

Secretary, by contract, provide for the 

establishment and operation of an Organ 

Procurement and Transplantation 

Network (OPTN). The OPTN, among 

other responsibilities, operates and 

maintains a national waiting list of 

individuals requiring organ transplants, 

maintains a computerized system for 

matching donor organs with transplant 

candidates on the waiting list, and 

operates a 24-hour system to facilitate 

matching organs with individuals 

included in the list. 

Data for the OPTN data system are 

collected from transplant hospitals, 

organ procurement organizations, and 

tissue-typing laboratories. The 

information is used to indicate the 

disease severity of transplant 

candidates, to monitor compliance of 

member organizations with OPTN rules 

and requirements, and to report 

periodically on the clinical and 

scientific status of organ donation and 

transplantation in this country. Data are 

used to develop transplant, donation 

and allocation policies, to determine if 

institutional members are complying 

with policy, to determine member 

specific performance, to ensure patient 

safety and to fulfill the requirements of 

the OPTN Final Rule. The practical 

utility of the data collection is further 

enhanced by requirements that the 

OPTN data must be made available, 

consistent with applicable laws, for use 

by OPTN members, the Scientific 

Registry of Transplant Recipients, the 

Department of Health and Human 

Services, and others for evaluation, 

research, patient information, and other 

important purposes. 

No revisions of the 26 data collection 

forms are proposed at this time; 

however, the OPTN is currently 

undergoing a review of the forms and 

expects to submit proposed revisions 

within the next year. 

The annual estimate of burden is as 

follows: 

Form Number of 

respondents 

Responses 

per 

respondents 

Total 

responses 

Hours per 

response 

Total burden 

hours 

Deceased Donor Registration .............................................. 58 216 12,528 0.7500 9,396.00 

Death referral data ............................................................... 58 12 696 10.0000 6,960.00 

Death Notification Referral—Eligible ................................... 58 161 9338 0.2000 1,867.60 

Death Notification Referral—Imminent ................................ 58 168 9744 0.5000 4,872.00 

Living Donor Registration .................................................... 308 39 12,012 0.6500 7,807.80 

Living Donor Follow-up ........................................................ 308 50 15,400 0.5000 7,700.00 

Donor Histocompatibility ...................................................... 156 131 20,436 0.1000 2,043.60 

Recipient Histocompatibility ................................................. 156 196 30,576 0.2000 6,115.20 

Heart Candidate Registration .............................................. 127 35 4,445 0.5000 2,222.50 

Lung Candidate Registration ............................................... 68 42 2,856 0.5000 1,428.00 

Heart/Lung Candidate Registration ..................................... 51 2 102 0.5000 51.00 

Thoracic Registration ........................................................... 127 36 4,572 0.7500 3,429.00 

Thoracic Follow-up ............................................................... 127 320 40,640 0.6500 26,416.00 

Kidney Candidate Registration ............................................ 241 183 44,103 0.5000 22,051.50 

Kidney Registration .............................................................. 241 83 20,003 0.7500 15,002.25 

Kidney Follow-up * ............................................................... 241 742 178,822 0.5500 98,352.10 

Liver Candidate Registration ............................................... 129 109 14,061 0.5000 7,030.50 

Liver Registration ................................................................. 129 58 7,482 0.6500 4,863.30 

Liver Follow-up ..................................................................... 129 519 66,951 0.5000 33,475.50 

Kidney/Pancreas Candidate Registration ............................ 143 14 2,002 0.5000 1,001.00 

Kidney/Pancreas Registration .............................................. 143 7 1,001 0.9000 900.90 

Kidney/Pancreas Follow-up ................................................. 143 85 12,155 0.8500 10,331.75 

Pancreas Candidate Registration ........................................ 143 7 1,001 0.5000 500.50 

Pancreas Registration .......................................................... 143 3 429 0.7500 321.75 

Pancreas Follow-up ............................................................. 143 20 2,860 0.6500 1,859.00 

Intestine Candidate Registration .......................................... 44 7 308 0.5000 154.00 

Intestine Registration ........................................................... 44 5 220 0.9000 198.00 

Intestine Follow-up ............................................................... 44 28 1,232 0.8500 1,047.20 

Post Transplant Malignancy ................................................ 684 10 6,840 0.2000 1,368.00 


jlentini on DSKJ8SOYB1PROD with NOTICES
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