Federal Register / Vol. 75, No. 88 / Friday, May 7, 2010 / Notices 25281 

capabilities should be incorporated? If 

not, why not? 

4. If certain changes are desirable as 

additional safeguards for the devices, 

how feasible is it to retrofit existing 

units in the field? 

5. Should manufacturers standardize 

their display format to ensure that 

treatment settings, protocols, and 

collimator positions are displayed 

taking human factors into consideration 

and are recorded for physician review? 

6. Should manufacturers submit more 

data to FDA as part of their premarket 

submissions for approval or clearance of 

devices, related to the safety of these 

devices? If so, why, and what data 

should be submitted? If not, why not? 

7. Should there be a mandatory ‘‘timeout’’ built into the equipment, similar to 

what already has been implemented for 

surgical procedures, to confirm that all 

settings for the equipment are correct 

and allow adequate time for QA? If not, 

why not? 

8. Should manufacturers provide 

better instructions and specifics (i.e. QA 

methodology) for acceptance testing 

and/or commissioning due to new and/ 

or unique features/capabilities? If so, 

why and what should be included? 

9. Other than requiring a facility to 

report to FDA, how can FDA ensure that 

facilities report to FDA significant 

under-doses and over-doses? Should 

there be a quantitative metric used to 

define a medical event similar to that 

used by the Nuclear Regulatory 

Commission (e.g. +/- 20% variation 

from intended dose)? 

10. What prevents users from 

participating in voluntary reporting? 

11. How can FDA encourage reporting 

and prevent workarounds even when no 

clinically significant adverse event 

occurs? 

B. User Training 

1. Should manufacturers provide 

training to ensure equipment users have 

adequate understanding of equipment 

capabilities, operating principles for the 

technology, general information about 

patient dose, and specific dose-related 

equipment features? If so, why, and 

what training should be provided? If 

not, why not? 

2. If manufacturers provide such 

training, which personnel should 

receive it? In your response, please 

consider dosimetrists, physicists, 

radiation therapists or technologists in 

other specialties and departmental 

administrators as well as physicians in 

all medical specialties who may operate 

radiation therapeutic equipment. 

3. If manufacturers provide such 

training, what is the most effective 

timing for a new installation and how 

frequently should it be repeated for 

optimum implementation? Should 

manufacturers recommend an internal 

training program for use by the facility 

to insure continued staff competence? 

4. For software patches and upgrades, 

how is the software tested for hazard 

analysis, verification and validation? 

Should manufacturers perform 

additional testing to adequately test 

software patches? 

5. Would standardizing terminology 

and standardizing design of control 

panels facilitate safe use of the 

equipment? 

6. Should custom-tailored educational 

material, such as pamphlets, pocket 

cards, videos etc. that highlight unique 

features of the equipment, be provided 

with new equipment? 

C. Quality Assurance Measures 

1. Is there a model QA program that 

exists which is widely accepted? If so, 

please describe. 

2. What types of QA should be the 

responsibility of the facility, the 

physicist, the operator, others? 

3. Should manufacturers provide QA 

procedures to medical facilities and 

users of radiation therapy devices? If so, 

why, and what instructions should be 

provided? If not, why not? How 

extensive should they be? 

4. Should manufacturers provide 

training on QA practices? If so, why, 

what type of training should be 

provided, and to which personnel? If 

not, why not and who should? 

III. Transcripts 

Please be advised that as soon as a 

transcript is available, it will be 

accessible at http:// 

www.regulations.gov. It may be viewed 

at the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD. A transcript will 

also be available in either hardcopy or 

on CD–ROM, after submission of a 

Freedom of Information request. Written 

requests are to be sent to Division of 

Freedom of Information (HFI–35), Office 

of Management Programs, Food and 

Drug Administration, 5600 Fishers 

Lane, rm. 6–30, Rockville, MD 20857. 

Dated: May 3, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–10754 Filed 5–6–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Amended 

Notice of Meeting 

Notice is hereby given of a change in 

the meeting of the Center for Scientific 

Review Special Emphasis Panel, May 

28, 2010, 12 p.m. to May 28, 2010, 2:30 

p.m., National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

which was published in the Federal 

Register on April 28, 2010, 75 FR 22412. 

The meeting has been changed to an 

Internet assisted meeting. The meeting 

time has been changed to 8 a.m. to 

7 p.m. The meeting location remains the 

same. The meeting is closed to the 

public. 

Dated: April 29, 2010. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–10873 Filed 5–6–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Amended 

Notice of Meeting 

Notice is hereby given of a change in 

the meeting of the Center for Scientific 

Review Special Emphasis Panel, May 

19, 2010, 12 p.m. to May 19, 2010, 

5 p.m., Tata Communications, 2355 

Dulles Corner Boulevard, 7th Floor, 

Herndon, VA 20171 which was 

published in the Federal Register on 

April 26, 2010, 75 FR 21641. 

The meeting has been changed to a 

Hybrid meeting. The meeting date, time 

and location remain the same. The 

meeting is closed to the public. 

Dated: April 29, 2010. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–10871 Filed 5–6–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0001] 

Food Protection Workshop; Public 

Workshop 

AGENCY: Food and Drug Administration, 

HHS. 


jlentini on DSKJ8SOYB1PROD with NOTICES
25282 Federal Register / Vol. 75, No. 88 / Friday, May 7, 2010 / Notices 

ACTION: Notice of public workshop. 

SUMMARY: The Food and Drug 

Administration (FDA), Office of 

Regulatory Affairs (ORA), Southwest 

Regional Office (SWRO), in cosponsorship with the University of 

Arkansas (UA) Institute of Food Science 

and Engineering, is announcing a public 

workshop entitled ‘‘Food Protection 

Workshop.’’ This public workshop is 

intended to provide information about 

food safety, food defense, the 

regulations authorized by the Public 

Health Security and Bioterrorism 

Preparedness and Response Act of 2002 

(the Bioterrorism Act), and other related 

subjects to the Food Protection Plan as 

it relates to food establishments such as 

farms, manufacturers, processors, 

distributors, retailers, and restaurants. 

Date and Time: This public workshop 

will be held on June 9 and 10, 2010, 

from 8 a.m. to 5 p.m. 

Location: The public workshop will 

be held at the Continuing Education 

Center, Two East Center St., 

Fayetteville, AR (located downtown). 

Contact: David Arvelo, Food and Drug 

Administration, Southwest Regional 

Office, 4040 North Central Expressway, 

suite 900, Dallas, TX 75204, 214–253– 

4952, FAX: 214–253–4970, or e-mail: 

david.arvelo@fda.hhs.gov. 

For information on accommodation 

options, visit http://www.uark.edu/ua/ 

foodpro/Workshops/Food_Safety_

Defense_Workshop.html or contact 

Steven C. Seideman, 2650 North Young 

Ave., Institute of Food Science & 

Engineering, University of Arkansas, 

Fayetteville, AR 72704, 479–575–4221, 

FAX: 479–575–2165, or e-mail: 

seideman@uark.edu. 

Registration: You are encouraged to 

register by May 26, 2010. The University 

of Arkansas has a $250 registration fee 

to cover the cost of facilities, materials, 

speakers, and breaks. There is no fee for 

FDA employees. Seats are limited; 

please submit your registration as soon 

as possible. Course space will be filled 

in order of receipt of registration. Those 

accepted into the course will receive 

confirmation. Registration will close 

after the course is filled. Registration at 

the site is not guaranteed but may be 

possible on a space available basis on 

the day of the public workshop 

beginning at 8 a.m. The cost of 

registration at the site is $350 payable 

to: ‘‘The University of Arkansas.’’ If you 

need special accommodations due to a 

disability, please contact Steven C. 

Seideman (see Contact) at least 14 days 

in advance. 

To register, please visit http:// 

www.uark.edu/ua/foodpro/Workshops/ 

Food_Safety_Defense_Workshop.html to 

register online or submit a check or 

money order for $250 payable to the 

‘‘The University of Arkansas.’’ Mail to: 

Institute of Food Science & Engineering, 

University of Arkansas, 2650 North 

Young Ave., Fayetteville, AR 72704 

along with the following information: 

Your name, affiliation, mailing address, 

phone number, fax, e-mail, and whether 

special accommodations are required. 

Transcripts: Transcripts of the public 

workshop will not be available due to 

the format of this workshop. Workshop 

handouts may be requested at cost 

through the Freedom of Information 

Office (HFI–35), Food and Drug 

Administration, 5600 Fishers Lane, rm. 

12A–16, Rockville, MD 20857, 

approximately 15 working days after the 

public workshop at a cost of 10 cents 

per page. 

SUPPLEMENTARY INFORMATION: This 

public workshop is being held in 

response to the large volume of food 

protection concerns from food 

establishments (such as farms, 

manufacturers, processors, distributors, 

retailers, and restaurants) originating 

from the area covered by the FDA Dallas 

District Office. The SWRO presents this 

workshop to help achieve objectives set 

forth in section 406 of the Food and 

Drug Administration Modernization Act 

of 1997 (21 U.S.C. 393), which include 

working closely with stakeholders and 

maximizing the availability and clarity 

of information to stakeholders and the 

public. This is consistent with the 

purposes of the Small Business 

Representative Program, which are in 

part to respond to industry inquiries, 

develop educational materials, sponsor 

workshops and conferences to provide 

firms, particularly small businesses, 

with firsthand working knowledge of 

FDA’s guidance, requirements, and 

compliance policies. This workshop is 

also consistent with the Small Business 

Regulatory Enforcement Fairness Act of 

1996 (Public Law 104–121), as outreach 

activities by Government agencies to 

small businesses. 

The goal of this public workshop is to 

present information that will enable 

food establishments (such as farms, 

manufacturers, processors, distributors, 

retailers, and restaurants) to better 

comply with any regulations authorized 

by the Public Health Security and 

Bioterrorism Preparedness and 

Response Act of 2002 (the Bioterrorism 

Act) relevant to such establishments, 

and to be aware of recommendations in 

food protection guidance, especially in 

light of growing concerns about food 

safety and defense. Information 

presented will be based on regulations, 

guidances, and information previously 

made available to the public. Topics to 

be discussed at the workshop include: 

(1) Food defense programs, (2) good 

manufacturing practices, (3) reportable 

food registry, (4) Hazard Analysis 

Critical Control Point (HACCP), (5) good 

agricultural practices, (6) food recalls, 

(7) pathogens of public health concern, 

and (8) risk management and 

vulnerability assessments and other 

related topics. For more information, 

please visit http://www.uark.edu/ua/ 

foodpro/Workshops/Food_Safety_

Defense_Workshop.html. FDA expects 

that participation in this public 

workshop will provide regulated 

industry with greater understanding of 

the regulatory and guidance 

perspectives on food protection and 

increase voluntary compliance and food 

defense awareness. 

Dated: May 3, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–10792 Filed 5–6–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Office of the Director, Office of 

Biotechnology Activities; Notice of a 

Safety Symposium 

There will be a safety symposium 

entitled ‘‘Gene-Modified T Cells: 

Challenges in Clinical Trial Design with 

Novel Receptors.’’ The meeting will be 

open to the public, with attendance 

limited to space available. Individuals 

who plan to attend and need special 

assistance, such as sign language 

interpretation or other reasonable 

accommodations, should notify the 

Contact Person listed below in advance 

of the meeting. For further information 

concerning this meeting contact Ms. 

Chezelle George, Administrative 

Assistant, Office of Biotechnology 

Activities, Office of the Director, 

National Institutes of Health, 6705 

Rockledge Drive, Room 750, Bethesda, 

MD 20892–7985, 301–496–9838, 

georgec@mail.nih.gov. 

Name of Committee: Recombinant DNA 

Advisory Committee. 

Date: June 15, 2010. 

Time: 8 a.m. to 5:30 p.m. 

Agenda: The Office of Biotechnology 

Activities (OBA) and NIH Recombinant DNA 

Advisory Committee will host a symposium 

entitled ‘‘Gene Modified T Cells: Challenges 

in Clinical Trial Design with Novel 

Receptors’’ on June 15, 2010 at the Rockville 

Hotel and Executive Center. Experts will 

discuss data from trials conducted to date, 

the selection of novel antigen targets, the 


jlentini on DSKJ8SOYB1PROD with NOTICES